Data / Medical devices / United Kingdom / Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics: FDA-registered device maker in Pencoed Bridgend, United Kingdom, 48 510(k) clearances and 7 PMA approvals

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

Ortho-Clinical Diagnostics is registered with the FDA (registration 3007111389) in Pencoed Bridgend, United Kingdom. It lists 50 device types. The FDA files 48 510(k) clearances and 7 PMA approvals under its listings, the newest dated October 29, 2025. 11 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007111389
Address: Felindre Meadows, Pencoed Bridgend, United Kingdom, CF35 5PZ
Owner or operator: QuidelOrtho Corporation (2024674)
Roles: Complaint file establishment, Manufacturer
First device listed: November 24, 2020
Registered through: 2026
Brand names listed: Ortho 7% BSA, QuickVue At Home COVID-19, QuickVue COVID-19 Test Control Swab Set, QuickVue SARS Antigen Test, Quidel Molecular Adenovirus Control Set (M110), Quidel Molecular Bordetella Control Set (M117), Quidel Molecular C. difficile Control Set (M108), Quidel Molecular GBS Control Set (M116) and more

Devices it lists

Device	Product code	Class	Role	Source
Acid, Folic, Radioimmunoassay	CGN	2	Manufacturer	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Manufacturer	accessdata.fda.gov
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus	MZO	2	Manufacturer	accessdata.fda.gov
Calibrator, Multi-Analyte Mixture	JIX	2	Manufacturer	accessdata.fda.gov
Calibrator, Primary	JIS	2	Manufacturer	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Manufacturer	accessdata.fda.gov
Column Chromatography & Color Development, Hydroxyproline	JMM	1	Manufacturer	accessdata.fda.gov
Coronavirus Antigen Detection Test System.	QKP	N	Manufacturer	accessdata.fda.gov
Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens	PMT	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	KLI	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Rubella	LFX	2	Manufacturer	accessdata.fda.gov
Ferritin, Antigen, Antiserum, Control	DBF	2	Manufacturer	accessdata.fda.gov
Fluorometric Method, Cpk Or Isoenzymes	JHX	2	Manufacturer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Manufacturer	accessdata.fda.gov
Hepatitis A Test (Antibody And Igm Antibody)	LOL	2	Manufacturer	accessdata.fda.gov
Immunoassay Method, Troponin Subunit	MMI	2	Manufacturer	accessdata.fda.gov
Kit, Serological, Negative Control	MJY	1	Manufacturer	accessdata.fda.gov
Kit, Serological, Positive Control	MJX	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Kit, Test,Alpha-Fetoprotein For Testicular Cancer	LOJ	2	Manufacturer	accessdata.fda.gov
Multi-Analyte Controls Unassayed	OHQ	1	Manufacturer	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Manufacturer	accessdata.fda.gov
Myoglobin, Antigen, Antiserum, Control	DDR	2	Manufacturer	accessdata.fda.gov
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	LTJ	2	Manufacturer	accessdata.fda.gov
Qualitative And Quantitative Hepatitis B Virus Antibody Assays	SEI	2	Manufacturer	accessdata.fda.gov
Radioassay, Triiodothyronine Uptake	KHQ	2	Manufacturer	accessdata.fda.gov
Radioassay, Vitamin B12	CDD	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, C-Peptides Of Proinsulin	JKD	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Cortisol	CGR	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Estradiol	CHP	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating Hormone	CGJ	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Free Thyroxine	CEC	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Luteinizing Hormone	CEP	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Parathyroid Hormone	CEW	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Progesterone	JLS	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)	CFT	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Testosterones And Dihydrotestosterone	CDZ	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Total Triiodothyronine	CDP	2	Manufacturer	accessdata.fda.gov
Reagent, Coronavirus Serological	QKO	N	Manufacturer	accessdata.fda.gov
Sars-Cov-2 Serology Test	QVP	2	Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Manufacturer	accessdata.fda.gov
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer	NIG	2	Manufacturer	accessdata.fda.gov
System, Test, Carcinoembryonic Antigen	DHX	2	Manufacturer	accessdata.fda.gov
System, Test, Human Chorionic Gonadotropin	DHA	2	Manufacturer	accessdata.fda.gov
System, Test, Immunological, Antigen, Tumor	MOI	2	Manufacturer	accessdata.fda.gov
System, Test, Vitamin D	MRG	2	Manufacturer	accessdata.fda.gov
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	LTK	2	Manufacturer	accessdata.fda.gov
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	LOM	2	Manufacturer	accessdata.fda.gov
Test, Hiv Detection	MZF	2	Manufacturer	accessdata.fda.gov
Test, Natriuretic Peptide	NBC	2	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.

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
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
February 25, 2020	K200236	VITROS BRAHMS PCT Reagent Pack and Calibrators	PMT	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
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
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
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
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
December 26, 2006	K063143	VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS	LFX	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
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 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 20, 2005	K052889	VITROS CA 19-9	NIG	Substantially Equivalent	Fujirebio Diagnostics,Inc.	accessdata.fda.gov
September 27, 2004	K042303	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS	JJX	Substantially Equivalent	Ortho-Clinical Diagnostics	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
January 17, 2003	K030067	VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS	MJX	Substantially Equivalent	Ortho-Clinical Diagnostics	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 29, 2001	K012561	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS	JJX	Substantially Equivalent	Ortho-Clinical Diagnostics	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 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

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
June 5, 2023	92662	Class II	Ongoing	VITROS Immunodiagnostic Products Troponin I ES Reagent Pack	Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.	accessdata.fda.gov
November 1, 2018	81682	Class II	Ongoing	VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years old) serum from individual	The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current Instructions for Use.	accessdata.fda.gov
March 7, 2017	76665	Class II	Terminated	VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK	Increased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagent Lots 1568, 1570, 1580 and 1590, due to background signals for these affected NT-proBNP lots that have been increasing with time since release testing, resulting in higher than expected VITROS Immunodiagnostic Products NT-proBNP level 1 calibrator signals produc	accessdata.fda.gov
October 5, 2016	75476	Class II	Terminated	VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892 - Reagent Pack, 2) UPN 10758750006250 / Product Code 6802893 - Calibrators For the quantitative measurement of intact	The device defect is a positive bias of up to 20% relative to the currently marketed Roche device. In addition, the firm states that during the investigation they discovered that the cleared reference interval (RI) was not set optimally at product launch in 2010 and that the upper limit in the IFU of 53.5pg/mL is too low and should be closer to 80 pg/mL. The	accessdata.fda.gov
July 28, 2016	74828	Class III	Terminated	VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code, Unique Device Identifier No. 10758750000227, IVD --- Ortho-Clinical Diagnostics Pencoed Bridgend CF35 5PZ UK For the in vitro quantitati	A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than expected frequency of customer calibration curves falling outside of the calibration quality parameters and therefore unusable to process samples. Customers using VITROS TSH Lot 5040 will potentially experience an unexpected increase in the unsuccessful calibration	accessdata.fda.gov
July 14, 2016	74764	Class II	Terminated	VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code; IVD -- Ortho-Clinical Diagnostics, Pencoed, Bridgend CF35 5PZ, UK --- The VITROS Estr	Ortho Clinical Diagnostics has issued a recall of their VITROS immunodiagnostics Estradiol Reagent assay. The firm was made aware of a potential cross-reactivity between the drug Fulvestrant and theVITROS Immunodiagnostic Estradiol Reagent assay. The firm conducted an internal investigation and was able to confirm biased positive (ranging from 1303-4046%) on	accessdata.fda.gov
June 2, 2016	74366	Class II	Terminated	VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical Diagnostics, For in vitro diagnostic use only. For the quantitative measurement of to	Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic Products Total T4 Reagent Packs may show a negative bias prior to the open pack storage limit of <= 8 weeks that is located in the Instructions for Use (IFU) for VITROS Immunodiagnostic Products Total T4 Reagent Pack.	accessdata.fda.gov
May 9, 2016	74346	Class III	Terminated	VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Pro	Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products AFP Reagent Pack product exhibit an increase in the reaction signal over time potentially resulting in the inability to calibrate and use the product.	accessdata.fda.gov
May 6, 2015	71176	Class III	Terminated	VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing	The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.	accessdata.fda.gov
August 6, 2014	68974	Class II	Terminated	VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. REF, IVD -- Ortho-Clinical Diagnostics Hig	VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has been observed producing sporadic lower than expected VITROS Anti-HCV test results due to an approximate signal loss of up to 66.2% which can result in unexpected negative test results being obtained for reactive sample fluids (quality control and patient samples).	accessdata.fda.gov
July 16, 2014	68890	Class II	Terminated	VITROS Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS CA 19-9 Reagent Packs are used on VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Int	Customers may receive positively biased results when using VITROS Immunodiagnostic Products CA 19-9 Total Reagent Packs, Lot 1320 and VITROS CA 19-9 Calibrators, Lot 1320 on the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. There is an unexpected observed change in CA 19-9 Calibrators	accessdata.fda.gov

Compare with other makers

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.