Ortho Clinical Diagnostics recalls
Ortho Clinical Diagnostics appears in 311 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes…
FDA Device · Class II · 2018-10-17 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793
FDA Device · Class II · 2018-10-10 · Ortho Clinical Diagnostics - VITROS Sodium Slides, Catalog # 837 9034
FDA Device · Class II · 2018-10-10 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997
FDA Device · Class II · 2018-10-10 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922
FDA Device · Class II · 2018-10-10 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
FDA Device · Class II · 2018-10-10 · Ortho Clinical Diagnostics - VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnost…
FDA Device · Class III · 2018-09-26 · Ortho Clinical Diagnostics - VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagn…
FDA Device · Class III · 2018-09-26 · Ortho Clinical Diagnostics - VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage For in vitro diagnostic use only
FDA Device · Class III · 2018-09-19 · Ortho Clinical Diagnostics - VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only
FDA Device · Class III · 2018-09-19 · Ortho Clinical Diagnostics - VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
FDA Device · Class II · 2018-07-11 · Ortho Clinical Diagnostics - VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic
FDA Device · Class II · 2018-03-14 · Ortho Clinical Diagnostics - VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic
FDA Device · Class II · 2018-03-14 · Ortho Clinical Diagnostics - VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic
FDA Device · Class II · 2018-03-14 · Ortho Clinical Diagnostics - VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic
FDA Device · Class II · 2018-03-14 · Ortho Clinical Diagnostics - VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic
FDA Device · Class II · 2018-03-14 · Ortho Clinical Diagnostics - VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600…
FDA Device · Class III · 2018-03-07 · Ortho Clinical Diagnostics - VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD
FDA Device · Class II · 2018-01-03 · Ortho Clinical Diagnostics - enGen Track System with TCAutomation Software Version 4.2
FDA Device · Class II · 2017-12-20 · Ortho Clinical Diagnostics - enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD
FDA Device · Class II · 2017-05-24 · Ortho Clinical Diagnostics - VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Di…
FDA Device · Class II · 2017-05-03 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5…
FDA Device · Class II · 2017-04-19 · Ortho Clinical Diagnostics - VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per sales unit) and REF/…
FDA Device · Class II · 2017-03-22 · Ortho Clinical Diagnostics - VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine
FDA Device · Class II · 2017-02-15 · Ortho Clinical Diagnostics - VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD
FDA Device · Class III · 2017-02-15 · Ortho Clinical Diagnostics - VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only
FDA Device · Class II · 2017-02-08 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892 - Reagent Pack, 2) UPN 1075875000625…
FDA Device · Class II · 2017-01-04 · Ortho Clinical Diagnostics - VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS¿ Chemistry Produ…
FDA Device · Class III · 2016-12-28 · Ortho Clinical Diagnostics - enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Versi…
FDA Device · Class II · 2016-11-02 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro diagnostic use only
FDA Device · Class III · 2016-11-02 · Ortho Clinical Diagnostics - VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit), Unique Device Identifier No. 10758750000340,…
FDA Device · Class II · 2016-10-26 · Ortho Clinical Diagnostics - VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales unit) and 832 9930 (90 slides per sales unit), Uniq…
FDA Device · Class II · 2016-10-26 · Ortho Clinical Diagnostics - VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides per sales unit) and 815 0112 (90 slides per sales unit), Uniqu…
FDA Device · Class II · 2016-10-26 · Ortho Clinical Diagnostics - VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales unit), Unique Device Identifier No. 10758750009572, R…
FDA Device · Class II · 2016-10-26 · Ortho Clinical Diagnostics - The VITROS¿ Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS¿ Chemistry Products HbA1c Reagent Kit, Generati…
FDA Device · Class III · 2016-09-21 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, I…
FDA Device · Class III · 2016-08-24 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2…
FDA Device · Class II · 2016-08-17 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clin…
FDA Device · Class II · 2016-08-10 · Ortho Clinical Diagnostics - VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or 20758750009111, IVD…
FDA Device · Class II · 2016-08-03 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD
FDA Device · Class III · 2016-07-20 · Ortho Clinical Diagnostics - enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above
FDA Device · Class III · 2016-07-20 · Ortho Clinical Diagnostics - VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Ge…
FDA Device · Class III · 2016-07-13 · Ortho Clinical Diagnostics - VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740
FDA Device · Class II · 2016-06-15 · Ortho Clinical Diagnostics - VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measur…
FDA Device · Class II · 2016-06-15 · Ortho Clinical Diagnostics - 1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2…
FDA Device · Class II · 2016-06-01 · Ortho Clinical Diagnostics - enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL NAME: enGen (TM) Tr…
FDA Device · Class II · 2016-05-04 · Ortho Clinical Diagnostics - VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110
FDA Device · Class II · 2016-04-13 · Ortho Clinical Diagnostics - VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, Un…
FDA Device · Class II · 2016-03-16 · Ortho Clinical Diagnostics - VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054
FDA Device · Class II · 2016-03-16 · Ortho Clinical Diagnostics - VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343
FDA Device · Class II · 2016-03-16 · Ortho Clinical Diagnostics