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 Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use on…
FDA Device · Class II · 2020-06-24 · Ortho Clinical Diagnostics - VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage: For in v…
FDA Device · Class II · 2020-06-24 · Ortho Clinical Diagnostics - VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The…
FDA Device · Class II · 2020-05-20 · Ortho Clinical Diagnostics - VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The V…
FDA Device · Class II · 2020-05-20 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
FDA Device · Class III · 2020-05-06 · Ortho Clinical Diagnostics - 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…
FDA Device · Class II · 2020-02-19 · Ortho Clinical Diagnostics - 7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dy…
FDA Device · Class II · 2020-01-01 · Ortho Clinical Diagnostics - Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium (Na+) and potassium…
FDA Device · Class II · 2020-01-01 · Ortho Clinical Diagnostics - VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-la…
FDA Device · Class II · 2019-11-13 · Ortho Clinical Diagnostics - VITROS chemistry Products K+ Slides, Catalog No. 8157596
FDA Device · Class II · 2019-11-13 · Ortho Clinical Diagnostics - VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry,…
FDA Device · Class II · 2019-11-13 · Ortho Clinical Diagnostics - VITROS 5600 Integrated System, clinical chemistry analyzer
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - VITROS Chemistry Products GLU Slides-Product Code:1707801
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - VITROS 4600 Chemistry System, clinical chemistry analyzer
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - VITROS 4600 Chemistry System, clinical chemistry analyzer
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - VITROS 250 Chemistry System, clinical chemistry analyzer
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - VITROS 350 Chemistry System, clinical chemistry analyzer
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - VITROS 250AT Chemistry System, clinical chemistry analyzer
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - VITROS 250 Chemistry System, clinical chemistry analyzer
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - VITROS 5600 Integrated System, clinical chemistry analyzer
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical tests on serum, urine,…
FDA Device · Class II · 2019-07-10 · Ortho Clinical Diagnostics - VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) Product Usage: Performs discrete clinical tests on serum, urine…
FDA Device · Class II · 2019-07-10 · Ortho Clinical Diagnostics - VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine,…
FDA Device · Class II · 2019-07-10 · Ortho Clinical Diagnostics - VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 10758750001330) Product Usage: Performs discrete clinical tests on se…
FDA Device · Class II · 2019-07-10 · Ortho Clinical Diagnostics - VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only
FDA Device · Class II · 2019-05-29 · Ortho Clinical Diagnostics - VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantitative, and…
FDA Device · Class II · 2019-05-15 · Ortho Clinical Diagnostics - VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 For use in the in vitro quantitative, semi-quantit…
FDA Device · Class II · 2019-05-15 · Ortho Clinical Diagnostics - VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitative, and…
FDA Device · Class II · 2019-05-15 · Ortho Clinical Diagnostics - VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For use in the in vitro quantitative, semi-quantitative, and qualitati…
FDA Device · Class II · 2019-05-15 · Ortho Clinical Diagnostics - VITROS¿ 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914 For use in the in vitro quantitative, semi-quanti…
FDA Device · Class II · 2019-05-15 · Ortho Clinical Diagnostics - VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 For use in the in vitro quantitative, semi-quantitative, an…
FDA Device · Class II · 2019-05-15 · Ortho Clinical Diagnostics - VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro quantitative, semi-quantitative, and qualitative mea…
FDA Device · Class II · 2019-05-15 · Ortho Clinical Diagnostics - VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended f…
FDA Device · Class II · 2019-05-01 · Ortho Clinical Diagnostics - VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only
FDA Device · Class II · 2019-03-20 · Ortho Clinical Diagnostics - VITROS Chemistry Products VALP Reagent Pack
FDA Device · Class II · 2019-02-27 · Ortho Clinical Diagnostics - Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3…
FDA Device · Class II · 2019-02-27 · Ortho Clinical Diagnostics - VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to hepatitis B e antigen…
FDA Device · Class II · 2019-01-09 · Ortho Clinical Diagnostics - VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only
FDA Device · Class II · 2019-01-09 · Ortho Clinical Diagnostics - VITROS HBeAg Reagent, Cat
FDA Device · Class II · 2019-01-09 · Ortho Clinical Diagnostics - VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical i…
FDA Device · Class II · 2018-12-26 · Ortho Clinical Diagnostics - VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of cl…
FDA Device · Class II · 2018-12-26 · Ortho Clinical Diagnostics - VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement o…
FDA Device · Class II · 2018-12-26 · Ortho Clinical Diagnostics - VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical i…
FDA Device · Class II · 2018-12-26 · Ortho Clinical Diagnostics - VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27
FDA Device · Class II · 2018-11-28 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantitative…
FDA Device · Class II · 2018-11-14 · Ortho Clinical Diagnostics - VITROS 5600 Integrated System- (Refurbished)
FDA Device · Class II · 2018-10-17 · Ortho Clinical Diagnostics