Ortho-Clinical Diagnostics: 119 recalls on record

Recalls filed with 1 agency: FDA (119).

First recall on record: August 1, 2012. Most recent: April 3, 2024.

Risk classification: Class II: 110 · Class III: 9

Most recent recalls

DateAgencyProduct
March 16, 2016FDAVITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 107…Z-1074-2016
March 16, 2016FDAVITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 1…Z-1075-2016
June 17, 2015FDAVITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical …Z-1728-2015
January 21, 2015FDAVITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diag…Z-0967-2015
December 31, 2014FDAVITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use…Z-0848-2015
October 22, 2014FDAVITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 68…Z-0077-2015
October 22, 2014FDAVITROS 5600 Integrated System, System Product Code 6802413. For use in the in vitro qu…Z-0078-2015
October 8, 2014FDAVITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For…Z-0007-2015
October 1, 2014FDAVITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection…Z-2671-2014
August 20, 2014FDAVITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITR…Z-2183-2014
August 20, 2014FDAVITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Produ…Z-2214-2014
August 13, 2014FDAVITROS 5600 Integrated System --- For use in the in vitro quantitative, semi-quantitative…Z-2141-2014
August 13, 2014FDAVITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quanti…Z-2139-2014
August 13, 2014FDAVITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Che…Z-2140-2014
June 25, 2014FDAVITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- …Z-1804-2014
June 25, 2014FDAVITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873 -- Fo…Z-1805-2014
June 18, 2014FDAenGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- Fo…Z-1741-2014
June 18, 2014FDAVITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnosti…Z-1735-2014
June 18, 2014FDAVITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numb…Z-1736-2014
June 18, 2014FDAenGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitat…Z-1738-2014
June 18, 2014FDAVITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnos…Z-1734-2014
June 11, 2014FDAenGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument …Z-1677-2014
May 28, 2014FDAVITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in huma…Z-1648-2014
May 7, 2014FDAVITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinic…Z-1519-2014
May 7, 2014FDAVITROS Chemistry Products FS Diluent Pack 3, REF 680 1754, 3 x 45 mL, (D1)/15 mL (D2), I…Z-1520-2014

Questions about this company

How many recalls does Ortho-Clinical Diagnostics have?
Recalert has 119 U.S. recalls on record for Ortho-Clinical Diagnostics, published between August 1, 2012 and April 3, 2024.
Which agencies have handled Ortho-Clinical Diagnostics recalls?
Ortho-Clinical Diagnostics appears as the recalling firm in recalls from: FDA (119).

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