Data / Medical devices / United States / Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: FDA-registered device maker in Rochester, NY, United States, 120 510(k) clearances and 7 PMA approvals

Name: Ortho-Clinical Diagnostics, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ortho-Clinical Diagnostics, Inc. is registered with the FDA (registration 1319681) in Rochester, NY, United States. It lists 137 device types. The FDA files 120 510(k) clearances and 7 PMA approvals under its listings, the newest dated October 29, 2025. 135 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1319681
FEI number: 1000136573
Address: 100 Indigo Creek Dr, Rochester, NY, United States, 14626
Owner or operator: QuidelOrtho Corporation (2024674)
Roles: Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer
First device listed: November 24, 2020
Registered through: 2026
Brand names listed: DAT Control, MTS DAT Card, MTS Diluent 2, MTS Diluent 2 PLUS, ORTHO Antibody Enhancement Solution, ORTHO Bovine Albumin Solution Polymerized, ORTHO Bovine Serum Albumin, 22% Protein Concentration, ORTHO Confidence System, ORTHO Optix Reader and more

Devices it lists

Device	Product code	Class	Role	Source
Acid, Folic, Radioimmunoassay	CGN	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Acid, Lactic, Enzymatic Method	KHP	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Acid, Uric, Uricase (Colorimetric)	KNK	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Albumin, Antigen, Antiserum, Control	DCF	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Alpha-1-Antitrypsin, Antigen, Antiserum, Control	DEM	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Antistreptolysin - Titer/Streptolysin O Reagent	GTQ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Apolipoproteins	MSJ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	MZO	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Azo Dye, Calcium	CJY	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Biuret (Colorimetric), Total Protein	CEK	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Bromcresol Green Dye-Binding, Albumin	CIX	2	Complaint file establishment, Specification developer	accessdata.fda.gov
C-Reactive Protein, Antigen, Antiserum, And Control	DCK	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Calibrator, Multi-Analyte Mixture	JIX	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Calibrator, Primary	JIS	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Calibrators, Drug Mixture	DKB	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Calibrators, Drug Specific	DLJ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Calibrators, Ethyl Alcohol	DNN	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	NQD	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Centrifuge, Cell-Washing, Automated For Immuno-Hematology	KSN	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Colorimetry, Acetaminophen	LDP	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Colorimetry, Cholinesterase	DIH	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Colorimetry, Salicylate	DKJ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Column Chromatography & Color Development, Hydroxyproline	JMM	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Complement C3, Antigen, Antiserum, Control	CZW	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Complement C4, Antigen, Antiserum, Control	DBI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Coronavirus Antigen Detection Test System.	QKP	N	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens	PMT	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Diazo Colorimetry, Bilirubin	CIG	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Differential Rate Kinetic Method, Cpk Or Isoenzymes	JHS	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Diluent, Blood Cell	GIF	1	Specification developer	accessdata.fda.gov
Drug Mixture Control Materials	DIF	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Electrode, Ion Specific, Potassium	CEM	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Electrode, Ion Specific, Sodium	JGS	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Electrode, Ion-Specific, Chloride	CGZ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzymatic Esterase--Oxidase, Cholesterol	CHH	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet	DMT	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzymatic Method, Creatinine	JFY	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzymatic Radiochemical Assay, Tobramycin	LDO	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzymatic, Carbon-Dioxide	KHS	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Amphetamine	DKZ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Barbiturate	DIS	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Benzodiazepine	JXM	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Carbamazepine	KLT	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Digitoxin	LFM	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Diphenylhydantoin	DIP	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Gentamicin	LCD	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Methadone	DJR	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	KLI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Phencyclidine	LCM	U	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Phenobarbital	DLZ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Theophylline	KLS	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Immunoassay, Valproic Acid	LEG	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Rubella	LFX	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	LIP	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Enzyme Linked Immunosorbent Assay, T. Cruzi	MIU	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Ferritin, Antigen, Antiserum, Control	DBF	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Ferrozine (Colorimetric) Iron Binding Capacity	JMO	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Flame Photometry, Lithium	JIH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Fluorometer, For Clinical Use	KHO	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Fluorometric Method, Cpk Or Isoenzymes	JHX	2	Complaint file establishment, Specification developer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Glucose Oxidase, Glucose	CGA	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Haptoglobin, Antigen, Antiserum, Control	DAD	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Hemoglobin A1c Test System	PDJ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Hepatitis A Test (Antibody And Igm Antibody)	LOL	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Immunoassay Method, Troponin Subunit	MMI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Interleukin 6	QLC	N	Manufacturer for export	accessdata.fda.gov
Kinetic Method, Gamma-Glutamyl Transpeptidase	JQB	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Kit, Quality Control For Blood Banking Reagents	KSF	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Kit, Serological, Negative Control	MJY	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Kit, Serological, Positive Control	MJX	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Kit, Test,Alpha-Fetoprotein For Testicular Cancer	LOJ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	LBS	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Ldl & Vldl Precipitation, Hdl	LBR	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Lectins And Protectins	KSI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	CDT	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Lipase-Esterase, Enzymatic, Photometric, Lipase	CHI	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Lowry (Colorimetric), Total Protein	JGP	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Media, Potentiating For In Vitro Diagnostic Use	KSG	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Method, Nephelometric, Immunoglobulins (G, A, M)	CFN	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Micro Pipette	JRC	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Multi-Analyte Controls Unassayed	OHQ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Myoglobin, Antigen, Antiserum, Control	DDR	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	CFJ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Alt/Sgpt	CKA	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/Sgot	CIT	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	CJE	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Phosphomolybdate (Colorimetric), Inorganic Phosphorus	CEO	1	Specification developer	accessdata.fda.gov
Photometric Method, Ammonia	JID	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Photometric Method, Iron (Non-Heme)	JIY	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Photometric Method, Magnesium	JGJ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Prealbumin, Antigen, Antiserum, Control	JZJ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	LTJ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Qualitative And Quantitative Hepatitis B Virus Antibody Assays	SEI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Radioassay, Triiodothyronine Uptake	KHQ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Radioassay, Vitamin B12	CDD	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Radioimmunoassay, C-Peptides Of Proinsulin	JKD	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Radioimmunoassay, Cortisol	CGR	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Radioimmunoassay, Estradiol	CHP	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating Hormone	CGJ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Radioimmunoassay, Free Thyroxine	CEC	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Radioimmunoassay, Luteinizing Hormone	CEP	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Radioimmunoassay, Parathyroid Hormone	CEW	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Radioimmunoassay, Progesterone	JLS	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)	CFT	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Radioimmunoassay, Testosterones And Dihydrotestosterone	CDZ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Radioimmunoassay, Total Triiodothyronine	CDP	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Radioimmunoassay, Vancomycin	LEH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Reagent, Coronavirus Serological	QKO	N	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Sars-Cov-2 Serology Test	QVP	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Starch-Dye Bound Polymer, Amylase	CIW	2	Complaint file establishment, Specification developer	accessdata.fda.gov
System, Test, Automated Blood Grouping And Antibody	KSZ	2	Complaint file establishment, Specification developer	accessdata.fda.gov
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer	NIG	2	Complaint file establishment, Specification developer	accessdata.fda.gov
System, Test, Carcinoembryonic Antigen	DHX	2	Complaint file establishment, Specification developer	accessdata.fda.gov
System, Test, Human Chorionic Gonadotropin	DHA	2	Complaint file establishment, Specification developer	accessdata.fda.gov
System, Test, Immunological, Antigen, Tumor	MOI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
System, Test, Low Density, Lipoprotein	MRR	1	Complaint file establishment, Specification developer	accessdata.fda.gov
System, Test, Rheumatoid Factor	DHR	2	Complaint file establishment, Specification developer	accessdata.fda.gov
System, Test, Vitamin D	MRG	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	LTK	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Equipment, Automated Bloodborne Pathogen	MZA	N	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	LOM	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Hiv Detection	MZF	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Test, Natriuretic Peptide	NBC	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Transferrin, Antigen, Antiserum, Control	DDG	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Urease, Photometric, Urea Nitrogen	CDN	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Urinary Homocystine (Nonquantitative) Test System	LPS	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Whole Human Serum, Antigen, Antiserum, Control	DGR	1	Complaint file establishment, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 120.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 29, 2025	K252393	VITROS Immunodiagnostic Products hs Troponin I Reagent Pack	MMI	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
August 28, 2024	K241534	VITROS Immunodiagnostic Products Syphilis Reagent Pack	LIP	Substantially Equivalent	Ortho Clinical Diagnostics	accessdata.fda.gov
May 8, 2024	K233581	VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack	DHA	Substantially Equivalent	Ortho Clinical Diagnostics	accessdata.fda.gov
September 5, 2023	K221197	VITROS Immunodiagnostic Products Intact PTH II Reagent Pack	CEW	Substantially Equivalent	Ortho Clinical Diagnostics	accessdata.fda.gov
August 23, 2023	K231517	VITROS Immunodiagnostic Products CEA Reagent Pack	DHX	Substantially Equivalent	Ortho Clinical Diagnostics	accessdata.fda.gov
August 9, 2023	K231525	VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack	NIG	Substantially Equivalent	Ortho Clinical Diagnostics	accessdata.fda.gov
May 5, 2023	DEN210040	VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators	QVP	Unknown	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
May 5, 2023	DEN210038	VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator	QVP	Unknown	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
December 12, 2022	K221355	VITROS Immuodiagnostic Products CA 125 II Reagent Pack	LTK	Substantially Equivalent	Ortho Clinical Diagnostics	accessdata.fda.gov
June 15, 2022	K213626	VITROS AFP	LOJ	Substantially Equivalent	Ortho Clinical Diagnostics	accessdata.fda.gov
January 28, 2022	K212648	VITROS Immunodiagnostic Products CK-MB Reagent Pack	JHX	Substantially Equivalent	Ortho Clinical Diagnostics	accessdata.fda.gov
October 4, 2021	K201312	VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack	NBC	Substantially Equivalent	Ortho Clinical Diagnostics	accessdata.fda.gov
August 13, 2021	K210858	VITROS Chemistry Products PHBR Slides	DLZ	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
February 25, 2020	K200236	VITROS BRAHMS PCT Reagent Pack and Calibrators	PMT	Substantially Equivalent	Ortho Clinical Diagnostics	accessdata.fda.gov
June 7, 2019	K191316	VITROS XT Chemistry Products ALB-TP Slides	CIX	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
April 26, 2019	K190807	VITROS XT Chemistry Products TBIL-ALKP Slides	CIG	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
April 3, 2019	K190520	VITROS XT Chemistry Products GLU-Ca Slides	CGA	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
March 27, 2019	K190490	VITROS XT Chemistry Products TRIG-CHOL Slides	CHH	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
March 14, 2019	K190326	VITROS XT Chemistry Products UREA-CREA Slides	CDN	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
October 30, 2018	K182072	VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides	CGZ	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
October 30, 2018	K182063	VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System	JFY	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
July 14, 2017	K160712	VITROS Chemistry Products hsCRP Reagent	DCK	Substantially Equivalent	Ortho Clinical Diagnostics	accessdata.fda.gov
May 16, 2017	K171168	VITROS Immunodiagnostic Products Insulin Calibrators	JIT	Substantially Equivalent	Ortho Clinical Diagnostics	accessdata.fda.gov
September 24, 2015	K152433	VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7	DCK	Substantially Equivalent	Ortho Clinical Diagnostics	accessdata.fda.gov
June 4, 2015	K142595	VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II	PDJ	Substantially Equivalent	Ortho Clinical Diagnostics	accessdata.fda.gov
May 31, 2013	K130332	VITROS CHEMISTRY PRODUCTS TRIG SLIDES	CDT	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
May 15, 2013	K123930	VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III	LPS	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
February 15, 2013	K121608	VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS	MRG	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
September 7, 2012	K120609	VITROS CHEMISTRY PRODUCTS DHDL SLIDES	LBS	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
October 22, 2010	K101921	VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT	CEW	Substantially Equivalent	Ortho-Clinical Diagnostics	accessdata.fda.gov
April 15, 2009	K072732	ORTHO T. CRUZI ELISA TEST SYSTEM	MIU	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
December 22, 2008	K083173	VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM	JLW	Substantially Equivalent	Ortho-Clinical Diagnostics	accessdata.fda.gov
October 23, 2008	K081543	VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM	JLW	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
June 30, 2008	K081411	VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2	JGS	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
December 7, 2007	K073157	VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2	CEM	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
September 20, 2007	K072440	VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)	CJY	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
April 9, 2007	K063720	VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS	DHA	Substantially Equivalent	Ortho-Clinical Diagnostics	accessdata.fda.gov
January 5, 2007	K062165	VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS	DIS	Substantially Equivalent	Ortho-Clinical Diagnostics	accessdata.fda.gov
December 28, 2006	K063164	VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV	LDJ	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
December 26, 2006	K063143	VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS	LFX	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
December 22, 2006	K062285	VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV	JXM	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
December 19, 2006	K062838	VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303	MMI	Substantially Equivalent	Ortho-Clinical Diagnostics	accessdata.fda.gov
December 15, 2006	K062460	VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III	DJG	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
November 22, 2006	K062637	VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V	DJR	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
November 22, 2006	K062094	VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V	LCM	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
November 22, 2006	K062077	VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS	DKZ	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
November 16, 2006	K062123	VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV	DIO	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
September 15, 2006	K060770	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS	LOL	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
September 14, 2006	K060678	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS	LOL	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
July 3, 2006	K060480	VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS	CGR	Substantially Equivalent	Ortho-Clinical Diagnostics	accessdata.fda.gov
June 15, 2006	K061464	VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668	JMO	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
June 6, 2006	K060632	VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158	NBC	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
December 23, 2005	K052867	VITROS CHEMISTRY PRODUCTS DTIBC REAGENT	JMO	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
December 23, 2005	K052819	VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III	DEM	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
December 20, 2005	K052889	VITROS CA 19-9	NIG	Substantially Equivalent	Fujirebio Diagnostics,Inc.	accessdata.fda.gov
December 14, 2005	K052645	VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;	GTQ	Substantially Equivalent	Ortho-Clinical Diagnostics	accessdata.fda.gov
February 7, 2005	K043386	VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III	LEH	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
February 7, 2005	K043384	VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III	LDO	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
January 6, 2005	K042479	VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE	LCD	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
December 9, 2004	K042838	VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & II	JIT	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
December 1, 2004	K042476	VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS	LEG	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
November 30, 2004	K042520	VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III	KLS	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
November 19, 2004	K042477	VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN	DDG	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
November 18, 2004	K042643	VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II	DCF	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
November 18, 2004	K042521	VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS	JIT	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
November 10, 2004	K042475	VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUC	CFN	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
October 28, 2004	K042006	VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE	LBS	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
October 19, 2004	K042494	VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III	CZW	Substantially Equivalent	Ortho-Clinical Diagnostics	accessdata.fda.gov
September 27, 2004	K042303	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS	JJX	Substantially Equivalent	Ortho-Clinical Diagnostics	accessdata.fda.gov
September 20, 2004	K041863	VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS	DHR	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
August 25, 2004	K041799	VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS	NQD	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
August 25, 2004	K041720	VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II	MRR	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
June 17, 2004	K041322	VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS	DHX	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
November 5, 2003	K033300	VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS	DDR	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
October 31, 2003	K033127	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS	JJX	Substantially Equivalent	Ortho-Clinical Diagnostics	accessdata.fda.gov
October 31, 2003	K032993	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS	JJX	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
August 13, 2003	K032296	VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS	JIS	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
August 7, 2003	K031924	VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1	JIT	Substantially Equivalent	Ortho-Clinical Diagnostics	accessdata.fda.gov
January 17, 2003	K030067	VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS	MJX	Substantially Equivalent	Ortho-Clinical Diagnostics	accessdata.fda.gov
December 10, 2002	K023876	VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1	JIX	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
December 10, 2002	K023875	VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4	CIX	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
January 24, 2002	K013899	VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS	CDD	Substantially Equivalent	Ortho-Clinical Diagnostics	accessdata.fda.gov
August 30, 2001	K012593	VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2	LBR	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
August 29, 2001	K012561	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS	JJX	Substantially Equivalent	Ortho-Clinical Diagnostics	accessdata.fda.gov
July 20, 2000	K001885	VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1	CDN	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
May 2, 2000	K001266	VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA	CGN	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
March 9, 2000	K000566	MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS	LTJ	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
December 22, 1999	K994145	VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS	JIS	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
February 2, 1999	K983690	VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK	MOI	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
January 29, 1999	K983674	VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS	JMM	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
November 4, 1998	K983507	VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY	JJY	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
November 3, 1998	K983513	VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS	JJY	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
January 13, 1998	K974644	VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS	JJX	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.	accessdata.fda.gov
October 22, 1997	K973331	VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)	DBF	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.	accessdata.fda.gov
September 25, 1997	K973517	VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS	JJY	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.	accessdata.fda.gov
March 18, 1997	K970643	VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)	CHP	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.	accessdata.fda.gov
March 18, 1997	K965142	VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)	CEC	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.	accessdata.fda.gov
February 20, 1997	K964982	VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)	CEP	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.	accessdata.fda.gov
February 18, 1997	K964960	VITROS CHEMISTRY PRODUCTS UPRO SLIDES	JGP	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.	accessdata.fda.gov
February 4, 1997	K964720	VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)	CGJ	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
July 20, 2011	P100001	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS	SEI	17	January 24, 2023	accessdata.fda.gov
May 11, 2011	P090028	VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS	LOM	17	January 24, 2023	accessdata.fda.gov
March 4, 2004	P030026	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR	SEI	37	January 24, 2023	accessdata.fda.gov
March 4, 2004	P030024	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOR	SEI	29	June 19, 2019	accessdata.fda.gov
August 30, 2001	P010021	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR	MZO	32	August 7, 2020	accessdata.fda.gov
April 27, 2001	P000044	VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS CONFIRMATORY KIT, AND VITROS IMMUNR	LOM	40	June 19, 2019	accessdata.fda.gov
September 29, 2000	P000014	VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORS	SEI	36	October 22, 2020	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI. Newest 100 of 135.

Initiated	Event	Class	Status	Product	Reason	Source
July 29, 2025	97409	Class II	Ongoing	Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.	VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho t	accessdata.fda.gov
July 9, 2025	97210	Class II	Ongoing	VITROS Chemistry Products Ca Slides; Catalog Number:	Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay calcium test results and potentially impact patient management. The imaging reflectometer algorithm detects excessive "spikes" (imperfections)	accessdata.fda.gov
June 12, 2025	97034	Class II	Ongoing	VITROS Chemistry Products OP Reagent Gen 15. Model Number:. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. One sales unit contains 6 Mi	Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results.	accessdata.fda.gov
June 10, 2025	97047	Class II	Ongoing	Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: Software Version: Not Applicable Product Description: VITROS Chemistry Products Performance Verif	Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PV	accessdata.fda.gov
May 9, 2025	96946	Class II	Ongoing	Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915	A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reag	accessdata.fda.gov
April 14, 2025	96784	Class II	Ongoing	VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.	Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.	accessdata.fda.gov
March 24, 2025	96870	Class II	Ongoing	Brand Name: Solana Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version: not applicable Product Description: One sales unit (kit) contains materials for 48 tests. One	It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results (only) of the assay.	accessdata.fda.gov
October 11, 2024	95634	Class II	Ongoing	VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740	May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher than 90 mg/L. User no way to know if the sample has to be diluted to measure again.	accessdata.fda.gov
July 10, 2024	94993	Class II	Ongoing	The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format	The reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB-TP Slides may shed dust and debris as they travel through the MicroSlide Subsystem of the VITROS XT 3400 or VITROS XT 7600 analyzer. This dust and debris may then settle onto VITROS Na+ (Sodium) Slides as they are processed through the same MicroSlide Subsystem,	accessdata.fda.gov
July 3, 2024	95020	Class II	Ongoing	VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2	It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the pre-treatment process causing the increase in "TM5-4MB" condition codes which lead to a delay of results.	accessdata.fda.gov
May 21, 2024	94770	Class II	Ongoing	VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Products FS Diluent Pack 3 comes with 3 packs per sales unit.	VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides.	accessdata.fda.gov
May 14, 2024	94734	Class III	Ongoing	VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of total iron-binding capac	Kit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration date for Lot 2953 is 24-Jul-2024. If used past its true expiration and the customer does not have their Assay Data Disk (ADD) updated, the system will allow them to use the expired calibrator which may bias the results. However, at this time the calibrator is withi	accessdata.fda.gov
May 8, 2024	94650	Class III	Ongoing	VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integr	The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is detectable by the user when the product fails to meet the required range during processing of RV Level 2 of this lot. There is a potential for a delay in patient test results should the user have a n	accessdata.fda.gov
March 1, 2024	94679	Class II	Ongoing	VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 - yellow, C3 - red).	Potential for positively biased results due to signal reduction over shelf life.	accessdata.fda.gov
January 26, 2024	93927	Class II	Ongoing	VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)	A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of Q	accessdata.fda.gov
January 26, 2024	93925	Class II	Ongoing	VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)	A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.	accessdata.fda.gov
January 22, 2024	93892	Class II	Ongoing	VITROS 3600 Immunodiagnostic System (New and Refurbished)	Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems which may lead to erroneous test results.	accessdata.fda.gov
November 27, 2023	93632	Class II	Ongoing	VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926	Affected lots may experience increased calibration failures or an increase in falsely elevated results.	accessdata.fda.gov
November 21, 2023	93621	Class II	Ongoing	QMS Tacrolimus Calibrators, Product code 10015573	Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11, 2024, due to improper storage that is expected to degrade the quality of the calibrator and render it unsuitable for use. Use of the affected lot may results in erroneous calibration results, causing delay in testing.	accessdata.fda.gov
October 10, 2023	93366	Class II	Ongoing	VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0	During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required	accessdata.fda.gov
August 9, 2023	92927	Class II	Ongoing	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Cod	Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactured between 07-Apr-2022 (Date code: 040722) and 19-Dec-2022 (Date code: 121922) may not perform as intended due to an out-of-specification barrel component. This may cause VITROS VersaTips and/or VITROS MicroTips to be improperly seated on the proboscis, which may	accessdata.fda.gov
May 18, 2023	92485	Class III	Ongoing	VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600	May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).	accessdata.fda.gov
November 17, 2022	91205	Class II	Ongoing	VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) Catalog Number: 6802892	Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results	accessdata.fda.gov
July 19, 2022	90681	Class II	Ongoing	VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458	Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.	accessdata.fda.gov
May 26, 2022	90408	Class II	Ongoing	Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems. Product Code: 6199960	On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).	accessdata.fda.gov
December 10, 2021	89362	Class II	Ongoing	VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.	The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact may include reduced drug dosage, or false positive or false negative results for bloodborne infectious disease assays when sample results are cl	accessdata.fda.gov
November 22, 2021	89183	Class II	Ongoing	VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack	Lower than expected results for VITROS Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190.	accessdata.fda.gov
October 15, 2021	88875	Class III	Terminated	VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems	Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect product. While the accuracy of patient test results is not affected by this issue, there is a potential for delayed results due to the troubleshooting of Quality Control res	accessdata.fda.gov
February 18, 2021	87390	Class II	Terminated	VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems Product Code: 1204668 Impact	Potential total iron-binding capacity (TIBC) results. The VITROS TIBC performance shift will start with the newest Generation (GEN) of VITROS Fe Slides (GEN 26), the potential shift in TIBC patient values of GEN 26 and above will be approximately 80 ug/dL lower across the measuring range than other available GENS of VITROS Fe Slides (GENs 22-25).	accessdata.fda.gov
February 12, 2021	87356	Class II	Terminated	VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SA	VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT Viral Transport Media	accessdata.fda.gov
January 14, 2021	87200	Class II	Terminated	VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays and sample and reagent fluid for MicroWell assays. In addition, VersaTips are used to dispense R1 Reagent Fluid into cuve	A deformity affecting a specific lot of VITROS Chemistry Products VersaTips. Deformed VersaTips results may be biased by up to +/-16% for both immunometric and competitive assays.	accessdata.fda.gov
November 20, 2020	86972	Class II	Terminated	enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Che	A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to results being associated with the wrong patient sample and potentially lead to inappropriate intervention with the potential for injury to the patient.	accessdata.fda.gov
July 20, 2020	86096	Class II	Terminated	VITROS XT3400 Chemistry System, Product code 6844458	When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.	accessdata.fda.gov
July 17, 2020	86038	Class II	Terminated	VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use o	The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures.	accessdata.fda.gov
May 20, 2020	85762	Class II	Terminated	VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979	Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances	accessdata.fda.gov
March 10, 2020	85298	Class III	Terminated	VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468	The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.	accessdata.fda.gov
July 8, 2019	83322	Class II	Terminated	VITROS 250 Chemistry System, clinical chemistry analyzer	Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System	accessdata.fda.gov
April 8, 2019	82784	Class II	Terminated	VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), pot	Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.	accessdata.fda.gov
March 20, 2019	82561	Class II	Terminated	VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of	Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported	accessdata.fda.gov
March 11, 2019	82366	Class II	Terminated	VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measureme	One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of this, sample dispense errors may lead to incorrect results being reported without an error code to alert the user.	accessdata.fda.gov
February 20, 2019	82311	Class II	Terminated	VITROS 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITRO	Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems	accessdata.fda.gov
January 22, 2019	82113	Class II	Terminated	VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1	Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.	accessdata.fda.gov
October 19, 2018	81563	Class II	Terminated	VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slid	Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.	accessdata.fda.gov
October 8, 2018	81376	Class II	Terminated	VITROS Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)	VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results	accessdata.fda.gov
August 28, 2018	81066	Class II	Terminated	VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) using the	The reagent pack exhibits the potential for an increased frequency of calibration failures.	accessdata.fda.gov
August 15, 2018	80959	Class II	Terminated	VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802413	Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.	accessdata.fda.gov
July 11, 2018	80715	Class III	Terminated	VITROS Chemistry Products CREA Slides, Product Code Product Usage: VITROS CREA Slides (Product Code ) - For in vitro diagnostic use only. VITROS Chemistry Products CREA Slides quantitatively measure creatinine (CREA) con	The slides did not meet the current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for serum and urine samples and therefore affecting the low end of the measuring range for this assay. The current low end measuring range is 0.05mg/dL for serum and 1.2mg/dL for urine. Based on the CREA testing results for the LoQ,	accessdata.fda.gov
July 11, 2018	80712	Class III	Terminated	VITROS Chemistry Products Cl- Slides, Product Code Product Usage: VITROS Cl Slides (Product Code ) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentrat	The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for urine samples. The measuring range (15-300 mmol/L) for urine samples when tested with the Cl- slide is not affected. The current Cl- LoQ is 5 mmol/L and the LoQ determined by this investigation is 15 mmol/L.	accessdata.fda.gov
July 11, 2018	80697	Class III	Terminated	VITROS Chemistry Products Cl- Slides, Product Code Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum and plasma using VITRO	The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observed around a triglyceride concentration 600mg/dL, however the current triglyceride interference claim states interference should not occur below 800mg/dL of triglyceride.	accessdata.fda.gov
May 9, 2018	80163	Class II	Terminated	VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic	There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for both quality control samples and patient samples.	accessdata.fda.gov
April 26, 2017	77172	Class II	Terminated	enGen Track System with TCAutomation Software Version 4.2	A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended location when samples are reintroduced back onto the enGEN track	accessdata.fda.gov
March 8, 2017	76752	Class II	Terminated	enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD	Software anomaly; Thermo-Fisher Scientific initially discovered and Ortho-Clinical Diagnostics, subsequently, confirmed a software anomaly that may potentially result in miss-associated sample IDs involving the communication between enGen TCAutomation (TCA) Bypass modules (manufactured by Thermo-Fisher Scientific) and the VITROS Analyzers. To date, no occurr	accessdata.fda.gov
February 21, 2017	76551	Class II	Terminated	VITROS Chemistry Products VANC Reagent, REF/Product Code, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- The VITROS VANC r	Potential for biased results generated using the specific lots of VITROS VANC Reagent. This can occur after the reagent packs are loaded onto the analyzer and stored within the on-analyzer stability date.	accessdata.fda.gov
February 1, 2017	76438	Class II	Terminated	VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per sales unit) and REF/Catalog Number/Product Code 8318925 (60 slide format / 300 slides per sales unit)	Intermittent imprecision in results generated using two specific lots of VITROS Li Slides.	accessdata.fda.gov
September 7, 2016	75167	Class II	Terminated	enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Version 3.6.1 and Below; IVD. --- Thermo Scientific Centrifuge Module has Product Code	Ortho confirmed that it is possible for the mis-association of sample identification and assay results due to an error with Thermo Fishers centrifuge module. It is possible for mis-associated assay results to be reported from the laboratory prior to the identification of the Cross Check error on the enGen Laboratory Automation System. Assay results associate	accessdata.fda.gov
August 11, 2016	74950	Class II	Terminated	VITROS Chemistry Products GLU Slides, REF/Product Code (300 slides per sales unit), Unique Device Identifier No. 10758750009572, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides qua	Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays. Ortho also tested several compounds following industry standard CLSI EP7-A2 for potential interference on VITROS GLU Slides during	accessdata.fda.gov
June 22, 2016	74772	Class III	Terminated	VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro diagnostic use only. For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnos	The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5 days. Increased results may occur on both the negative and positive Controls. The positive Control, although showing elevated results, was still within acceptable performance.	accessdata.fda.gov
May 16, 2016	74354	Class III	Terminated	enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD	If the user selects the Comment or Interpretation option (in the enGEN.gsb file), and the numerical results fall between Negative and Reactive, the IM incorrectly displays the interpretive text as Borderline and sends the incorrect text to the LIS. The IFU states the interpretation term for these numerical result values is Retest?. The difference in terminol	accessdata.fda.gov
April 6, 2016	73887	Class II	Terminated	VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnosti	Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated results.	accessdata.fda.gov
March 17, 2016	73616	Class II	Terminated	enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL NAME: enGen (TM) Track System -- NOTE: Outside the US the system is also known as VITROS Automation	The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may loosen from its correct position above the vibration feeder support plate and migrate to under the support plate. If this occurs, the uncapped sample tubes may hit the cable, and sample fluid (e.g., serum) may splash from the tube and into another tube or onto the	accessdata.fda.gov
February 18, 2016	73441	Class II	Terminated	1) VITROS Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS Immunodiagnostic Products Total Beta-hCG II Calibrators (Unique Device Ide	When testing was conducted using certain lots, VITROS Systems generated results within the measuring range for samples known to not contain measurable hCG. The system reported results up to approximately 7.40 mIU/mL (IU/L) for patient samples that should have been less than the measuring range of the assay (<2.39 mIU/mL (IU/L)).	accessdata.fda.gov
February 16, 2016	73429	Class II	Terminated	VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. Intended for use in the in vitro measurement of a variety of analytes of clinical interest.	The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situation where a module that is intended to be de-energized will remain energized only if the associated AC power cord is unplugged.	accessdata.fda.gov
December 21, 2015	72979	Class II	Terminated	VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, Unique Device Identifier No. 10758750001330; IVD. Product Usage: For in vitro diagn	Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).	accessdata.fda.gov
November 3, 2015	72597	Class II	Terminated	VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitativ	Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems continue to operate and process results without notification to the User, possibly producing erroneous results.	accessdata.fda.gov
September 10, 2015	72220	Class II	Terminated	VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identif	Software Anomaly during ADD Installation on VITROS 5,1 FS Chemistry Systems using Software Versions 2.2.1 through 2.8. The user modified parameters would not be saved as expected, but remained changed to the default values obtained from the ADD disk.	accessdata.fda.gov
June 30, 2015	71619	Class II	Terminated	VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identif	Software anomaly may occur during the installation of an Assay Data Diskette (ADD) using Software Versions 2.2.1 through 2.8. If the user is utilizing User- Configured (Modified) parameters, ALL default settings are restored in the VITROS 5,1 FS Chemistry System from the ADD instead of retaining the user modified parameters.	accessdata.fda.gov
May 6, 2015	71174	Class II	Terminated	enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all of the following system components: Recapper Caps (Product Codes 952238 or 6844286 only), Recapper Module (230V) or Recapper Modu	Recapper Caps may fall off of, or be knocked from sample tubes placed in the storage racks of entry/exit modules. The gripper may grab a tube at the wrong height and drop the tube in the Rack Entry/Exit or Rack Exit module. These situations may result in splashing of bio-hazardous fluid. Sample cross-contamination may occur with an uncapped tube in the rack.	accessdata.fda.gov
April 6, 2015	70918	Class II	Terminated	VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg),	Software anomaly regarding urine samples that require acidified pretreatment. The software has allowed urine samples for assays that require acidified pretreatment to be metered from the same sample container as assays that required no pretreatment when the sample was programmed.	accessdata.fda.gov
April 6, 2015	70917	Class II	Terminated	VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.	Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased patient results.	accessdata.fda.gov
March 10, 2015	70685	Class II	Terminated	Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Global Trade Item	Software Anomaly; It is possible for the device to process samples with a cartridge other than the intended cartridge, potentially leading to erroneous patient results. If this anomaly occurred previously, an indication would be a series of results that were similar across multiple samples (i.e., results could be believable or outside of the Reportable Range	accessdata.fda.gov
December 29, 2014	70264	Class II	Terminated	VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS 5,1 FS Chemistry System, VITROS 3600 Immunodiagnostics System, VITROS 4600 Chemistry System, VITROS 5600 Integra	In combination with the Batch Programming option (only) for programming samples, the hand-held barcode scanner unexpectedly skips sample cup positions within a sample tray. This issue only occurs when using the Batch Programming option; all other sample programming options function as intended.	accessdata.fda.gov
November 19, 2014	69830	Class II	Terminated	VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical in	Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.	accessdata.fda.gov
September 29, 2014	69727	Class III	Terminated	VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System 1) VITROS 4600 - in vitro quantitative measurement of a variety of a	Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2.	accessdata.fda.gov
September 8, 2014	69234	Class II	Terminated	VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of cl	Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing confirmed that when using calibrator barcode labels supplied with VITROS Chemistry Products Calibrator Kits 1, 2, 3, 4, 6, or 9, an unexpected assay calibration may occur if assay targ	accessdata.fda.gov
July 7, 2014	68790	Class II	Terminated	VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.	Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number.	accessdata.fda.gov
April 17, 2014	68269	Class II	Terminated	enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measurement of a variety of analytes of clinical interest --- The VITROS 5,1 FS Chemistry System with enGen	Software anomaly: potential buffer timeout issues when using enGen (TM) Laboratory Automation Systems Configured with TCAutomation (TM) Software v3.5.	accessdata.fda.gov
April 10, 2014	68271	Class II	Terminated	VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.	Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The Micr	accessdata.fda.gov
April 10, 2014	68270	Class II	Terminated	enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a variety of analytes of clinical interest; for pre-analytical and post-analytical sample and data management. ---	Software anomaly: potential for delay in the reporting of patient sample test results when using enGen with TCAutomation Software v2.6, v3.2 and v3.5 Configured with Bypass Modules for ADVIA Centaur, Abbott Architect, VITROS and/or Tosoh AIA Systems.	accessdata.fda.gov
March 26, 2014	67883	Class II	Terminated	VITROS Chemistry Products Specialty Diluent, REF, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY	Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Protein (CRP) results only to be generated when using VITROS Chemistry Products Specialty Diluent (Lot F3168) or VITROS Chemistry Products FS Diluent Pack 3 (Lot 01-3266). The VITROS Instructions for Use states that if the if a C-reactive protein concentration exceeds	accessdata.fda.gov
March 20, 2014	68263	Class II	Terminated	enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a variety of analytes of clinical interest --- Background: The	Software Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires follow-up action, such as dilution or retesting due to a mechanical issue, it is possible for that sample to be routed to the sample storage drawer (Storage) prior to the completion of the necessary pending action. A delay in patient test result(s) reporting could o	accessdata.fda.gov
March 5, 2014	67788	Class II	Terminated	VITROS Chemistry Products CRBM Slides, REF, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in ser	The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM Slides, Lot 3920-0080-8403.	accessdata.fda.gov
February 20, 2014	67643	Class II	Terminated	VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and t	Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.	accessdata.fda.gov
January 15, 2014	67439	Class III	Terminated	VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG #, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK --- For use in the calibr	Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators, Lots 0091 through 0235, used with VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Packs, may generate negatively biased results. As a result, users must immediately discontinue using all current lots of VITROS 25-OH Vitamin D	accessdata.fda.gov
January 9, 2014	67282	Class II	Terminated	VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in USA by Ortho- Clinical Diagnostics, Inc. 100 Indigo Creek Drive, Rochester, NY 1462	An incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (filter) that may cause a delay in the ability to obtain and report TBIL, Bu, Bc, and derived tests results. The correct assay value is 0.8658.	accessdata.fda.gov
October 25, 2013	66900	Class II	Terminated	VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs	Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent Packs due to false positive results.	accessdata.fda.gov
October 17, 2013	66774	Class II	Terminated	VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Technology Blvd Rochester, NY 14652 VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine usi	Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results.	accessdata.fda.gov
October 10, 2013	66498	Class II	Terminated	VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a disposable, intermediate container used in making automatic (auto)-dilutions on the VITROS 2	Ortho Clinical Diagnostics issued a product correction notification for VITROS Chemistry Mixing Cup Arrays utilized on VITROS 250 and VITROS 350 Chemistry Systems. Increase in Software error due to affected Mixing Cup Arrays.	accessdata.fda.gov
October 9, 2013	66496	Class II	Terminated	VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative measurement of OC 125 de	Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products CA 125 II Reagent Pack and Calibrators due to a positive shift in patient results.	accessdata.fda.gov
October 8, 2013	66467	Class II	Terminated	enGen Track System with enGen Select v5.0 with autoverification enabled Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of	Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen Select V5.0 & enGen Custom v3.2.2 due to an anomaly that affects the autoverification feature and custom rules that depend upon data elements used by the referenced enGen Systems.	accessdata.fda.gov
October 4, 2013	66474	Class II	Terminated	VITROS Chemistry Products COCM Reagent	Inaccurate quality control results.	accessdata.fda.gov
June 12, 2013	65572	Class II	Terminated	VITROS Chemistry Products ACET Slides, 90 slides/pack; catalog number 1037274 VITROS Chemistry Products ACET Slides quantitatively measure acetaminophen (ACET) concentration in serum and plasma using VITROS 250/350/950/5	Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.	accessdata.fda.gov
June 6, 2013	65472	Class II	Terminated	Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4) 6802413 Product Usage: The CM/RT incubator processes Microslide reagents with the following VITROS systems: 1) VITRO	Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incubator due to becoming worn before their replacement.	accessdata.fda.gov
May 9, 2013	65247	Class III	Terminated	VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products K+ Slides quantitatively measure potassium (K+) concentration in s	While performing interval testing, Ortho Clinical Diagnostics (OCD) determined that a surfactant was unintentionally added to VITROS Chemistry Products K+ Slides during the manufacturing process.	accessdata.fda.gov
May 6, 2013	65207	Class II	Terminated	1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refurbished (product code 6801890) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative me	There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.	accessdata.fda.gov
April 3, 2013	64901	Class III	Terminated	VITROS Immunodiagnostic Products CK-MB Calibrators, REF, IVD, Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnos	Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 degrees Celsius (-4 degrees Farenheit) generated invalid calibrations that were detected by positively biased quality control results.	accessdata.fda.gov
April 1, 2013	64874	Class II	Terminated	VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.	The firm is recalling the specific lot due to lower than expected results.	accessdata.fda.gov
March 14, 2013	64707	Class II	Terminated	VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.	Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values outside of expected intervals when using VITROS Chemistry Products PHBR Slides. OCD's investigation confirmed that positively biased values for patient samples could be obtained that may not be detected by qualit	accessdata.fda.gov
February 7, 2013	64577	Class II	Terminated	VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System Refurbished, Product Code 6801890. Intended for use in the measurement of a variety of chemistry analytes.	Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS Systems may be out of its manufacturing specifications. Extension springs are part of the slide alignment guide assembly. During an internal evaluation in its manufacturing facility, it was discovered that an extension spring had insufficient force. If the extension sprin	accessdata.fda.gov
December 13, 2012	63934	Class II	Terminated	Ortho Clinical Diagnostics VITROS Chemistry Products Vapor Adsorption Cartridge REF/CAT No.. VITROS Vapor Adsorption Cartridges are used to remove vapor contaminants that may potentially interfere with Signal Reagent use	Some VITROS Chemistry Products Vapor Adsorption Cartridge CAT No. 6800100 cartons incorrectly contain a Particulate Cartridge Part No. J19612. In some instances, the Particulate Cartridge has been inadvertently installed on the VITROS System instead of the intended VITROS Vapor Adsorption Cartridge which may bias results.	accessdata.fda.gov
November 1, 2012	64739	Class III	Terminated	VITROS Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) i	Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an inability to obtain a valid calibration.	accessdata.fda.gov

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Updated October 29, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.