Brand

Ortho-clinical Diagnostics Recalls

142 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Ortho-clinical Diagnostics.

142Total Recalls
0Critical
16.1MUnits Affected
Feb 27, 2024Most Recent
All Recalls

Every Ortho-clinical Diagnostics Recall

Sorted by most recent. Click any recall for full details.

142 recalls
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per sales unit) and RE...
Diagnostic Devices·94 affected·Feb 1, 2017
RecallFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD; used in conjunction with VITROS Chemistry Products Calib...
Diagnostic Devices·160 affected·Jan 5, 2017
High RiskFDA
Ortho-clinical Diagnostics
VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concen...
Diagnostic Devices·659,957 affected·Dec 20, 2016
High RiskFDA
Ortho-clinical Diagnostics
enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Ver...
Diagnostic Devices·60 affected·Sep 7, 2016
High RiskFDA
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), Un...
Diabetes Devices·60,372 affected·Aug 11, 2016
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales unit), Unique Device Identifier No. 10758750009572...
Diabetes Devices·192,459 affected·Aug 11, 2016
RecallFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227,...
Diagnostic Devices·2,883 affected·Jul 28, 2016
High RiskFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855...
Diagnostic Devices·1,620 affected·Jul 14, 2016
RecallFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro diagnostic use only. For use in monitoring the perf...
Diagnostic Devices·1,621 affected·Jun 22, 2016
RecallFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent ...
Diagnostic Devices·1,517 affected·May 24, 2016
RecallFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho...
Diagnostic Devices·6,471 affected·May 9, 2016
RecallFDA
Ortho-clinical Diagnostics
The VITROS¿ Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS¿ Chemistry Products HbA1c Reagent Kit, Genera...
Diagnostic Devices·520 affected·Apr 19, 2016
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (re...
Medical Devices·5,600 affected·Apr 6, 2016
High RiskFDA
Ortho-clinical Diagnostics
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative meas...
Diagnostic Devices·218 affected·Apr 6, 2016
High RiskFDA
Ortho-clinical Diagnostics
enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL NAME: enGen (TM) ...
Diagnostic Devices·19 affected·Mar 17, 2016
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. Intended for use in the in vitro measuremen...
Medical Devices·2,101 affected·Feb 16, 2016
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750002740; IVD. Product Usage: For use in ...
Diagnostic Devices·1,009 affected·Dec 21, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132; and VITROS 5,1 FS Chemistry Syste...
Diagnostic Devices·994 affected·Dec 21, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD. Product Usage: For in vitro...
Diagnostic Devices·885 affected·Dec 21, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, ...
Diagnostic Devices·802 affected·Dec 21, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343; IVD. Product Usage: For in vitr...
Diagnostic Devices·163 affected·Dec 21, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry Syste...
Diagnostic Devices·51 affected·Nov 3, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below; IVD...
Diagnostic Devices·157 affected·Nov 3, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Soft...
Diagnostic Devices·200 affected·Nov 3, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemi...
Diagnostic Devices·6,801,375 affected·Jun 30, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management f...
Diagnostic Devices·2,387 affected·Apr 6, 2015
High RiskFDA
Ortho-clinical Diagnostics
Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical and post-analytical sample ...
Diagnostic Devices·2,387 affected·Apr 6, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management fo...
Diagnostic Devices·255 affected·Apr 6, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitativ...
Diagnostic Devices·658 affected·Nov 19, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD --- Ortho Clinical Diagnostics. The VIT...
Diagnostic Devices·339 affected·Nov 19, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-...
Diagnostic Devices·1,830 affected·Nov 19, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistry System is in...
Diagnostic Devices·97 affected·Sep 8, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry ...
Diagnostic Devices·339 affected·Aug 20, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C vir...
Diagnostic Devices·463 affected·Aug 6, 2014
High RiskFDA
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¿ EC...
Diagnostic Devices·475 affected·Jul 16, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VI...
Diagnostic Devices·5,906 affected·Jul 15, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety ...
Diagnostic Devices·142 affected·Jul 7, 2014
High RiskFDA
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 vitr...
Diagnostic Devices·81 affected·Jul 7, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- For in vitro diagnostic use only --- VITROS Chem...
Diagnostic Devices·612 affected·May 12, 2014
High RiskFDA
Ortho-clinical Diagnostics
enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measurement of a variety...
Diagnostic Devices·6 affected·Apr 17, 2014
High RiskFDA
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.
Diagnostic Devices·597 affected·Apr 10, 2014
High RiskFDA
Ortho-clinical Diagnostics
enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a variety of analytes of clin...
Diagnostic Devices·31 affected·Apr 10, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use.
Diagnostic Devices·835 affected·Apr 10, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.
Diagnostic Devices·82 affected·Apr 10, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY
Diagnostic Devices·1,656 affected·Mar 26, 2014
High RiskFDA
Ortho-clinical Diagnostics
enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantit...
Diagnostic Devices·20 affected·Mar 20, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the V...
Diagnostic Devices·583 affected·Feb 20, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chem...
Diagnostic Devices·284 affected·Jan 29, 2014