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 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750002740
FDA Device · Class II · 2016-03-16 · Ortho Clinical Diagnostics - VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132
FDA Device · Class II · 2016-03-16 · Ortho Clinical Diagnostics - VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Softwa…
FDA Device · Class II · 2016-01-20 · Ortho Clinical Diagnostics - VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry System…
FDA Device · Class II · 2016-01-20 · Ortho Clinical Diagnostics - VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below
FDA Device · Class II · 2016-01-20 · Ortho Clinical Diagnostics - VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Softwa…
FDA Device · Class II · 2016-01-20 · Ortho Clinical Diagnostics - VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Orth…
FDA Device · Class III · 2015-11-11 · Ortho Clinical Diagnostics - VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemist…
FDA Device · Class II · 2015-11-11 · Ortho Clinical Diagnostics - VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemist…
FDA Device · Class II · 2015-09-09 · Ortho Clinical Diagnostics - VITROS 5600 Chemistry System, Software Version 3.2 & Below
FDA Device · Class II · 2015-06-17 · Ortho Clinical Diagnostics - enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all of the following system components: Recapper Cap…
FDA Device · Class II · 2015-06-17 · Ortho Clinical Diagnostics - VITROS 4600 Chemistry System, Software Version 3.2 & Below
FDA Device · Class II · 2015-06-17 · Ortho Clinical Diagnostics - Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical and post-analytical sample and d…
FDA Device · Class II · 2015-06-17 · Ortho Clinical Diagnostics - VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management for in…
FDA Device · Class II · 2015-06-17 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics…
FDA Device · Class III · 2015-06-10 · Ortho Clinical Diagnostics - Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITRO…
FDA Device · Class II · 2015-05-06 · Ortho Clinical Diagnostics - VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS 5,1 FS Chemistry System, VITROS…
FDA Device · Class II · 2015-03-18 · Ortho Clinical Diagnostics - VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integ…
FDA Device · Class III · 2015-01-28 · Ortho Clinical Diagnostics - VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD --- Ortho Clinical Diagnostics
FDA Device · Class II · 2015-01-21 · Ortho Clinical Diagnostics - VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics
FDA Device · Class II · 2015-01-21 · Ortho Clinical Diagnostics - VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics
FDA Device · Class II · 2015-01-21 · Ortho Clinical Diagnostics - VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only
FDA Device · Class II · 2014-12-31 · Ortho Clinical Diagnostics - VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445
FDA Device · Class II · 2014-10-22 · Ortho Clinical Diagnostics - VITROS 5600 Integrated System, System Product Code 6802413
FDA Device · Class II · 2014-10-22 · Ortho Clinical Diagnostics - VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only
FDA Device · Class II · 2014-10-08 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus…
FDA Device · Class II · 2014-10-01 · Ortho Clinical Diagnostics - VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev
FDA Device · Class II · 2014-08-20 · Ortho Clinical Diagnostics - VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS¿ CA 19-9 Reagent Packs are used on VITROS¿ ECi/ECi…
FDA Device · Class II · 2014-08-20 · Ortho Clinical Diagnostics - VITROS 5600 Integrated System --- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of anal…
FDA Device · Class II · 2014-08-13 · Ortho Clinical Diagnostics - VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of…
FDA Device · Class II · 2014-08-13 · Ortho Clinical Diagnostics - VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chemistry System is intended for use in the in vitro…
FDA Device · Class II · 2014-08-13 · Ortho Clinical Diagnostics - VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- For in vitro diagnostic use only --- VITROS Chemis…
FDA Device · Class II · 2014-06-25 · Ortho Clinical Diagnostics - VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873 -- For in vitro diagnostic use only --- VITROS Chemistr…
FDA Device · Class II · 2014-06-25 · Ortho Clinical Diagnostics - enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measurement of a variety o…
FDA Device · Class II · 2014-06-18 · Ortho Clinical Diagnostics - VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use
FDA Device · Class II · 2014-06-18 · Ortho Clinical Diagnostics - enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a variety of analytes of clinical…
FDA Device · Class II · 2014-06-18 · Ortho Clinical Diagnostics - VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use
FDA Device · Class II · 2014-06-18 · Ortho Clinical Diagnostics - VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use
FDA Device · Class II · 2014-06-18 · Ortho Clinical Diagnostics - enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitat…
FDA Device · Class II · 2014-06-11 · Ortho Clinical Diagnostics - VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS…
FDA Device · Class II · 2014-05-28 · Ortho Clinical Diagnostics - VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc
FDA Device · Class II · 2014-05-07 · Ortho Clinical Diagnostics - VITROS Chemistry Products FS Diluent Pack 3, REF 680 1754, 3 x 45 mL, (D1)/15 mL (D2), IVD --- Ortho-Clinical Diagnostics, Inc
FDA Device · Class II · 2014-05-07 · Ortho Clinical Diagnostics - VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemis…
FDA Device · Class II · 2014-04-30 · Ortho Clinical Diagnostics - VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc
FDA Device · Class II · 2014-04-23 · Ortho Clinical Diagnostics - VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315
FDA Device · Class II · 2014-03-26 · Ortho Clinical Diagnostics - VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators
FDA Device · Class III · 2014-03-19 · Ortho Clinical Diagnostics - VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Technology Blvd Rochester, NY 14652 VITROS Na+ Slides…
FDA Device · Class II · 2014-03-05 · Ortho Clinical Diagnostics - VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemistry P…
FDA Device · Class II · 2014-03-05 · Ortho Clinical Diagnostics - enGen Track System with enGen Select v5.0 with autoverification enabled Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory…
FDA Device · Class II · 2014-02-19 · Ortho Clinical Diagnostics - VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a disposable,…
FDA Device · Class II · 2014-02-19 · Ortho Clinical Diagnostics