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

Ortho-Clinical Diagnostics, Inc.: FDA-registered device maker in Rochester, NY, United States, 41 510(k) clearances

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 1319808) in Rochester, NY, United States. It lists 53 device types. The FDA files 41 510(k) clearances under its listings, the newest dated July 14, 2017. 13 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1319808
FEI number: 1000305841
Address: 1000 Lee RD., Rochester, NY, United States, 14606
Owner or operator: QuidelOrtho Corporation (2024674)
Roles: Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler
First device listed: December 15, 2022
Registered through: 2026
Brand names listed: Ortho 7% BSA, VITROS 4600 Chemistry System, VITROS 4600 Chemistry System Refurbished, VITROS 5,1 FS Chemistry System, VITROS 5,1 FS Chemistry System Refurbished, VITROS 5600 Integrated System, VITROS 5600 Integrated System Certified, VITROS 5600 Integrated System Refurbished and more

Devices it lists

Device	Product code	Class	Role	Source
Albumin, Antigen, Antiserum, Control	DCF	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Alpha-1-Antitrypsin, Antigen, Antiserum, Control	DEM	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Manufacturer	accessdata.fda.gov
Antistreptolysin - Titer/Streptolysin O Reagent	GTQ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Apolipoproteins	MSJ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Azo Dye, Calcium	CJY	2	Manufacturer	accessdata.fda.gov
Bromcresol Green Dye-Binding, Albumin	CIX	2	Manufacturer	accessdata.fda.gov
C-Reactive Protein, Antigen, Antiserum, And Control	DCK	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Calibrator, Multi-Analyte Mixture	JIX	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Calibrator, Primary	JIS	2	Manufacturer, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler	accessdata.fda.gov
Calibrators, Drug Mixture	DKB	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Calibrators, Drug Specific	DLJ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Calibrators, Ethyl Alcohol	DNN	2	Manufacturer	accessdata.fda.gov
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	NQD	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Complement C3, Antigen, Antiserum, Control	CZW	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Complement C4, Antigen, Antiserum, Control	DBI	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Diluent, Blood Cell	GIF	1	Manufacturer	accessdata.fda.gov
Drug Mixture Control Materials	DIF	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet	DMT	2	Manufacturer	accessdata.fda.gov
Enzymatic Radiochemical Assay, Tobramycin	LDO	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Amphetamine	DKZ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Barbiturate	DIS	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Benzodiazepine	JXM	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Diphenylhydantoin	DIP	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Gentamicin	LCD	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Methadone	DJR	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Phencyclidine	LCM	U	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Theophylline	KLS	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Valproic Acid	LEG	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Repackager or relabeler	accessdata.fda.gov
Ferrozine (Colorimetric) Iron Binding Capacity	JMO	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
General Purpose Reagent	PPM	1	Manufacturer	accessdata.fda.gov
Haptoglobin, Antigen, Antiserum, Control	DAD	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Hemoglobin A1c Test System	PDJ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	LBS	1	Manufacturer	accessdata.fda.gov
Ldl & Vldl Precipitation, Hdl	LBR	1	Manufacturer	accessdata.fda.gov
Lowry (Colorimetric), Total Protein	JGP	2	Manufacturer	accessdata.fda.gov
Method, Nephelometric, Immunoglobulins (G, A, M)	CFN	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Photometric Method, Ammonia	JID	1	Manufacturer	accessdata.fda.gov
Photometric Method, Magnesium	JGJ	1	Manufacturer	accessdata.fda.gov
Prealbumin, Antigen, Antiserum, Control	JZJ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Vancomycin	LEH	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Test, Low Density, Lipoprotein	MRR	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Test, Rheumatoid Factor	DHR	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Transferrin, Antigen, Antiserum, Control	DDG	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Urinary Homocystine (Nonquantitative) Test System	LPS	2	Manufacturer, Repackager or relabeler	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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
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 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
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
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
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 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
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
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 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 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
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
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
February 18, 1997	K964960	VITROS CHEMISTRY PRODUCTS UPRO SLIDES	JGP	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
March 21, 1994	K934273	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)	DMT	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
April 1, 1982	K820723	KODAK EKTACHEM CLINICAL CHEM. NH3	JID	Substantially Equivalent	Eastman Kodak Company	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
February 27, 2024	94174	Class II	Ongoing	VITROS Performance Verifier I	The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (E	accessdata.fda.gov
May 8, 2023	92440	Class II	Ongoing	VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Sys	Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Within the reference interval, the highest bias observed in selected sample testing investigation was +35.3% for IgM; -4.3% for IgG; +12.3% for IgA; -6.9% for C3; -6.6% for C4; and -17.8% for transferrin. False	accessdata.fda.gov
December 11, 2018	81806	Class II	Terminated	VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Che	Negative bias results when using VITROS VALP Reagent, GEN 25.	accessdata.fda.gov
September 22, 2017	79155	Class II	Terminated	VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic	This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.	accessdata.fda.gov
January 5, 2017	76200	Class III	Terminated	VITROS Chemistry Products FS Calibrator 1, REF 12 x 3 mL, Rx ONLY, IVD; used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS/4600 Chemistry and integrated Systems. --- Ortho-Clini	The company received a customer complaint for the inability to calibrate VITROS Chemistry Products dLDL Reagent when using VITROS FS Calibrator 1, Lot 91461 and ADD (DRV 5908). Assay Data Disk (ADD) DRV versions 5904, 5905, 5906, 5907, 5908, 5909, and 5910 are all affected by this issue.	accessdata.fda.gov
May 24, 2016	74363	Class III	Terminated	VITROS Chemistry Products Calibrator Kit 29, REF/Product Code, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF, and Assay Data Disk (ADD), REF/Product Code 6801876 (Unique Dev	Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC Reagent GEN 30 product. Ortho's investigation confirmed that incorrect calibration mathematics were assigned to the Calibrator Kit 29 Lots 2915 and 2995 supporting dTIBC Reagent GEN 30 product.	accessdata.fda.gov
April 19, 2016	74009	Class III	Terminated	The VITROS Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS Chemistry Products HbA1c Reagent Kit, Generation 6 (GEN 6) and Assay Data Disk (ADD), Data Release Versions (DRV) 5873, 5874, 587	There is an incorrect value (data/calibration mathematics) on ADDs. This incorrect value will prevent a successful calibration of the assay.	accessdata.fda.gov
September 28, 2015	72289	Class III	Terminated	VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical Diagnostics, Inc. --- VITROS Chemistry Products Calibrator Kit 9 is us	The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9, Lot 0954.	accessdata.fda.gov
July 15, 2014	68840	Class II	Terminated	VITROS Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN 59 and VITROS Chemi	Inability to calibrate or use VITROS NH3 DT Slides, GEN 59 with VITROS Chemistry Products DT Calibrator Kit, Lot 44 when CDM PROM 0168 or 0169 is installed on VITROS DT60/DT60 II Chemistry Systems.	accessdata.fda.gov
May 12, 2014	68286	Class II	Terminated	VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- For in vitro diagnostic use only --- VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Produ	Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process was not complete prior to calibrator value assignment for VITROS (R) Chemistry Products hsCRP Reagent (Product Code 6801739), Generation (GEN) 28.	accessdata.fda.gov
January 29, 2014	67509	Class II	Terminated	VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and VITROS DT Calibrator Ki	Customers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides (REF/Product Code 6802721), GEN 82, on the VITROS DT II System, when using Calibration Data Module (CDM) Rev. 168 (REF/Product Code ), as CDM 168 does not contain calibration parameters for DT CRSC.	accessdata.fda.gov
April 26, 2012	61790	Not yet classified	Terminated	VITROS 5600 Integrated System Software Version 1.6 & Below Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS C	Ortho Clinical Diagnostics is recalling VITROS 5600 Integrated System Software Version 1.6 and below because of an anomaly that may inadvertently add a surfactant to a CurveTip position.	accessdata.fda.gov
March 15, 2012	61409	Not yet classified	Terminated	VITROS&amp;amp;amp;reg; 3600 Immunodiagnostic System Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Imm	Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure.	accessdata.fda.gov

Compare with other makers

Updated March 22, 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.