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

Ortho-Clinical Diagnostics, Inc.: FDA-registered device maker in Raritan, NJ, United States, 107 510(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 2250051) in Raritan, NJ, United States. It lists 124 device types. The FDA files 107 510(k) clearances and 7 PMA approvals under its listings, the newest dated May 8, 2024. 16 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2250051
Address: 1001 US Highway 202, Raritan, NJ, United States, 08869
Owner or operator: QuidelOrtho Corporation (2024674)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, 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	accessdata.fda.gov
Acid, Lactic, Enzymatic Method	KHP	1	Complaint file establishment	accessdata.fda.gov
Acid, Uric, Uricase (Colorimetric)	KNK	1	Complaint file establishment	accessdata.fda.gov
Albumin, Antigen, Antiserum, Control	DCF	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Alpha-1-Antitrypsin, Antigen, Antiserum, Control	DEM	2	Complaint file establishment	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Complaint file establishment	accessdata.fda.gov
Antistreptolysin - Titer/Streptolysin O Reagent	GTQ	1	Complaint file establishment	accessdata.fda.gov
Apolipoproteins	MSJ	1	Complaint file establishment	accessdata.fda.gov
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	MZO	2	Complaint file establishment	accessdata.fda.gov
Azo Dye, Calcium	CJY	2	Complaint file establishment	accessdata.fda.gov
Biuret (Colorimetric), Total Protein	CEK	2	Complaint file establishment	accessdata.fda.gov
Bromcresol Green Dye-Binding, Albumin	CIX	2	Complaint file establishment	accessdata.fda.gov
C-Reactive Protein, Antigen, Antiserum, And Control	DCK	2	Complaint file establishment	accessdata.fda.gov
Calibrator, Multi-Analyte Mixture	JIX	2	Complaint file establishment	accessdata.fda.gov
Calibrator, Primary	JIS	2	Complaint file establishment	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Complaint file establishment	accessdata.fda.gov
Calibrators, Drug Mixture	DKB	2	Complaint file establishment	accessdata.fda.gov
Calibrators, Drug Specific	DLJ	2	Complaint file establishment	accessdata.fda.gov
Calibrators, Ethyl Alcohol	DNN	2	Complaint file establishment	accessdata.fda.gov
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	NQD	2	Complaint file establishment	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	accessdata.fda.gov
Colorimetry, Cholinesterase	DIH	1	Complaint file establishment	accessdata.fda.gov
Colorimetry, Salicylate	DKJ	2	Complaint file establishment	accessdata.fda.gov
Complement C3, Antigen, Antiserum, Control	CZW	2	Complaint file establishment	accessdata.fda.gov
Complement C4, Antigen, Antiserum, Control	DBI	2	Complaint file establishment	accessdata.fda.gov
Coronavirus Antigen Detection Test System.	QKP	N	Complaint file establishment	accessdata.fda.gov
Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens	PMT	2	Complaint file establishment	accessdata.fda.gov
Diazo Colorimetry, Bilirubin	CIG	2	Complaint file establishment	accessdata.fda.gov
Differential Rate Kinetic Method, Cpk Or Isoenzymes	JHS	2	Complaint file establishment	accessdata.fda.gov
Drug Mixture Control Materials	DIF	1	Complaint file establishment	accessdata.fda.gov
Electrode, Ion Specific, Potassium	CEM	2	Complaint file establishment	accessdata.fda.gov
Electrode, Ion Specific, Sodium	JGS	2	Complaint file establishment	accessdata.fda.gov
Electrode, Ion-Specific, Chloride	CGZ	2	Complaint file establishment	accessdata.fda.gov
Enzymatic Esterase--Oxidase, Cholesterol	CHH	1	Complaint file establishment	accessdata.fda.gov
Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet	DMT	2	Complaint file establishment	accessdata.fda.gov
Enzymatic Method, Creatinine	JFY	2	Complaint file establishment	accessdata.fda.gov
Enzymatic Radiochemical Assay, Tobramycin	LDO	2	Complaint file establishment	accessdata.fda.gov
Enzymatic, Carbon-Dioxide	KHS	2	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Amphetamine	DKZ	2	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Barbiturate	DIS	2	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Benzodiazepine	JXM	2	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Carbamazepine	KLT	2	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	2	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Digitoxin	LFM	2	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Diphenylhydantoin	DIP	2	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Gentamicin	LCD	2	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Methadone	DJR	2	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	KLI	2	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Phencyclidine	LCM	U	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Theophylline	KLS	2	Complaint file establishment	accessdata.fda.gov
Enzyme Immunoassay, Valproic Acid	LEG	2	Complaint file establishment	accessdata.fda.gov
Enzyme Linked Immunosorbent Assay, T. Cruzi	MIU	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Ferrozine (Colorimetric) Iron Binding Capacity	JMO	1	Complaint file establishment	accessdata.fda.gov
Flame Photometry, Lithium	JIH	2	Complaint file establishment	accessdata.fda.gov
Fluorometer, For Clinical Use	KHO	1	Complaint file establishment	accessdata.fda.gov
Fluorometric Method, Cpk Or Isoenzymes	JHX	2	Complaint file establishment	accessdata.fda.gov
General Purpose Reagent	PPM	1	Complaint file establishment	accessdata.fda.gov
Glucose Oxidase, Glucose	CGA	2	Complaint file establishment	accessdata.fda.gov
Haptoglobin, Antigen, Antiserum, Control	DAD	2	Complaint file establishment	accessdata.fda.gov
Hemoglobin A1c Test System	PDJ	2	Complaint file establishment	accessdata.fda.gov
Hepatitis A Test (Antibody And Igm Antibody)	LOL	2	Complaint file establishment	accessdata.fda.gov
Immunoassay Method, Troponin Subunit	MMI	2	Complaint file establishment	accessdata.fda.gov
Kinetic Method, Gamma-Glutamyl Transpeptidase	JQB	1	Complaint file establishment	accessdata.fda.gov
Kit, Quality Control For Blood Banking Reagents	KSF	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Kit, Serological, Negative Control	MJY	1	Complaint file establishment	accessdata.fda.gov
Kit, Serological, Positive Control	MJX	1	Complaint file establishment	accessdata.fda.gov
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	LBS	1	Complaint file establishment	accessdata.fda.gov
Ldl & Vldl Precipitation, Hdl	LBR	1	Complaint file establishment	accessdata.fda.gov
Lectins And Protectins	KSI	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	CDT	1	Complaint file establishment	accessdata.fda.gov
Lipase-Esterase, Enzymatic, Photometric, Lipase	CHI	1	Complaint file establishment	accessdata.fda.gov
Lowry (Colorimetric), Total Protein	JGP	2	Complaint file establishment	accessdata.fda.gov
Media, Potentiating For In Vitro Diagnostic Use	KSG	2	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Method, Nephelometric, Immunoglobulins (G, A, M)	CFN	2	Complaint file establishment	accessdata.fda.gov
Micro Pipette	JRC	1	Complaint file establishment	accessdata.fda.gov
Multi-Analyte Controls Unassayed	OHQ	1	Complaint file establishment	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Complaint file establishment	accessdata.fda.gov
Myoglobin, Antigen, Antiserum, Control	DDR	2	Complaint file establishment	accessdata.fda.gov
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	CFJ	2	Complaint file establishment	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Alt/Sgpt	CKA	1	Complaint file establishment	accessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/Sgot	CIT	2	Complaint file establishment	accessdata.fda.gov
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	CJE	2	Complaint file establishment	accessdata.fda.gov
Photometric Method, Ammonia	JID	1	Complaint file establishment	accessdata.fda.gov
Photometric Method, Iron (Non-Heme)	JIY	1	Complaint file establishment	accessdata.fda.gov
Photometric Method, Magnesium	JGJ	1	Complaint file establishment	accessdata.fda.gov
Prealbumin, Antigen, Antiserum, Control	JZJ	1	Complaint file establishment	accessdata.fda.gov
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	LTJ	2	Complaint file establishment	accessdata.fda.gov
Qualitative And Quantitative Hepatitis B Virus Antibody Assays	SEI	2	Complaint file establishment	accessdata.fda.gov
Radioassay, Triiodothyronine Uptake	KHQ	2	Complaint file establishment	accessdata.fda.gov
Radioimmunoassay, Cortisol	CGR	2	Complaint file establishment	accessdata.fda.gov
Radioimmunoassay, Estradiol	CHP	1	Complaint file establishment	accessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating Hormone	CGJ	1	Complaint file establishment	accessdata.fda.gov
Radioimmunoassay, Free Thyroxine	CEC	2	Complaint file establishment	accessdata.fda.gov
Radioimmunoassay, Parathyroid Hormone	CEW	2	Complaint file establishment	accessdata.fda.gov
Radioimmunoassay, Progesterone	JLS	1	Complaint file establishment	accessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)	CFT	1	Complaint file establishment	accessdata.fda.gov
Radioimmunoassay, Testosterones And Dihydrotestosterone	CDZ	1	Complaint file establishment	accessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	2	Complaint file establishment	accessdata.fda.gov
Radioimmunoassay, Total Triiodothyronine	CDP	2	Complaint file establishment	accessdata.fda.gov
Radioimmunoassay, Vancomycin	LEH	2	Complaint file establishment	accessdata.fda.gov
Reagent, Coronavirus Serological	QKO	N	Complaint file establishment	accessdata.fda.gov
Sars-Cov-2 Serology Test	QVP	2	Complaint file establishment	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Complaint file establishment	accessdata.fda.gov
Starch-Dye Bound Polymer, Amylase	CIW	2	Complaint file establishment	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	accessdata.fda.gov
System, Test, Carcinoembryonic Antigen	DHX	2	Complaint file establishment	accessdata.fda.gov
System, Test, Human Chorionic Gonadotropin	DHA	2	Complaint file establishment	accessdata.fda.gov
System, Test, Immunological, Antigen, Tumor	MOI	2	Complaint file establishment	accessdata.fda.gov
System, Test, Low Density, Lipoprotein	MRR	1	Complaint file establishment	accessdata.fda.gov
System, Test, Rheumatoid Factor	DHR	2	Complaint file establishment	accessdata.fda.gov
System, Test, Vitamin D	MRG	2	Complaint file establishment	accessdata.fda.gov
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	LTK	2	Complaint file establishment	accessdata.fda.gov
Test, Equipment, Automated Bloodborne Pathogen	MZA	N	Complaint file establishment	accessdata.fda.gov
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	LOM	2	Complaint file establishment	accessdata.fda.gov
Test, Hiv Detection	MZF	2	Complaint file establishment	accessdata.fda.gov
Test, Natriuretic Peptide	NBC	2	Complaint file establishment	accessdata.fda.gov
Transferrin, Antigen, Antiserum, Control	DDG	2	Complaint file establishment	accessdata.fda.gov
Urease, Photometric, Urea Nitrogen	CDN	2	Complaint file establishment	accessdata.fda.gov
Urinary Homocystine (Nonquantitative) Test System	LPS	2	Complaint file establishment	accessdata.fda.gov
Whole Human Serum, Antigen, Antiserum, Control	DGR	1	Complaint file establishment, Manufacturer	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 107.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
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
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
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
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
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 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
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
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
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 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
December 18, 1996	K964721	VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)	KLI	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.	accessdata.fda.gov
October 18, 1996	K962919	VITROS IMMUNODIAGNOSTIC SYSTEM	KHO	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.	accessdata.fda.gov
December 18, 1995	K954933	EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN	LDP	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.	accessdata.fda.gov
July 31, 1995	K953197	EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP)	DCK	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.	accessdata.fda.gov
October 20, 1994	K942610	KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)	LFM	Substantially Equivalent	Eastman Kodak Company	accessdata.fda.gov
March 21, 1994	K934273	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)	DMT	Substantially Equivalent	Eastman Kodak Company	accessdata.fda.gov
January 26, 1993	K924488	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI)	JIH	Substantially Equivalent	Eastman Kodak Company	accessdata.fda.gov
July 10, 1992	K922072	KODAK EKTACHEM 250 ANALYER	JJE	Substantially Equivalent	Eastman Kodak Company	accessdata.fda.gov
February 4, 1991	K910143	KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE)	JIY	Substantially Equivalent	Eastman Kodak Company	accessdata.fda.gov
August 22, 1990	K903189	KODATROL LIQUID CONTROL LEVELS I & II	DIF	Substantially Equivalent	Eastman Kodak Company	accessdata.fda.gov
July 16, 1990	K902356	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI)	DKJ	Substantially Equivalent	Eastman Kodak Company	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.

Initiated	Event	Class	Status	Product	Reason	Source
April 17, 2023	92254	Class II	Ongoing	VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. Product Code: 6842905	Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis	accessdata.fda.gov
April 14, 2023	92245	Class II	Ongoing	VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrat	Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing	accessdata.fda.gov
March 10, 2023	92055	Class II	Ongoing	VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS C	MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable	accessdata.fda.gov
March 9, 2023	92017	Class II	Ongoing	VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV): DRVs 6213 through 6218 supporting VITROS Calibrators. Product Code: 61	Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed patients results	accessdata.fda.gov
October 13, 2022	91051	Class II	Ongoing	VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code: 8568040. VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/5,1 FS/46	Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT Slides, for all lots of slide generation 22 (GEN 22). The erroneous mathematics on the calibration disk prevents the VITROS 250/350 Chemistry System from successfully calibrating, leading to delayed r	accessdata.fda.gov
March 25, 2022	90047	Class II	Ongoing	VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922	Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision obser	accessdata.fda.gov
September 10, 2021	88737	Class II	Terminated	VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems	VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results	accessdata.fda.gov
December 15, 2020	87019	Class II	Terminated	VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code	Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides	accessdata.fda.gov
December 11, 2020	87028	Class II	Ongoing	VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cartridge) Product Code: 8001133 Quantitatively measure creatine kinase MB (CK-MB) ac	VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference	accessdata.fda.gov
October 16, 2020	86669	Class III	Ongoing	VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Ch	Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures	accessdata.fda.gov
September 30, 2020	86573	Class II	Terminated	VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection	Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control	accessdata.fda.gov
December 16, 2019	84654	Class II	Terminated	VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+,	Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2	accessdata.fda.gov
October 14, 2019	84123	Class II	Terminated	7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dynamic) range using the VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 56	Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 days	accessdata.fda.gov
November 29, 2018	81767	Class II	Terminated	Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantit	A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.	accessdata.fda.gov
July 12, 2018	80717	Class II	Ongoing	VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266	The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations low	accessdata.fda.gov
July 10, 2017	78724	Class III	Terminated	VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Used as a control for th	VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements for the AST Analyte (only) when the product is stored refrigerated for up to 6 months.	accessdata.fda.gov

Compare with other makers

Updated May 8, 2024. 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.