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
RecallFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D C...
Diagnostic Devices·1,554 affected·Jan 15, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in ...
Diagnostic Devices·64 affected·Jan 9, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
Diagnostic Devices·1,920 affected·Oct 25, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Technology Blvd Rochester, NY 14652 VITROS Na+ Sl...
Diagnostic Devices·548,663 affected·Oct 17, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemis...
Diagnostic Devices·19,368 affected·Oct 17, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a dispo...
Medical Devices·6,380 affected·Oct 10, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products COCM Reagent
Diagnostic Devices·3,342 affected·Oct 4, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products PROT Slides packaged as 90 slides/pack catalog number 8208431 VITROS PROT Slides quantitatively measure protei...
Medical Devices·19,438 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products SALI Slides packaged as 90 slides/pack catalog number 1314343 VITROS SALI Slides quantitatively measure salicy...
Medical Devices·15,492 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products ALKP Slides, 300 slides/pack; catalog number 1053180 VITROS ALKP Slides quantitatively measure alkaline phosph...
Medical Devices·183,267 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products PHOS Slides packaged as 300 slides/pack catalog number 1513209 VITROS PHOS Slides quantitatively measure phosp...
Medical Devices·81,382 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 81...
Medical Devices·70,125 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211 VITROS ALB Slides quantitatively measure (ALB) concentratio...
Medical Devices·16,583 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Li Slides packaged as 300 slides/pack catalog number 8318925 and packaged as 90 slides/pack catalog number 1632...
Medical Devices·62,039 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093 and packaged as 90 slides/pack catalog number 1921...
Medical Devices·101,976 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products DGXN Slides packaged as 90 slides/pack catalog number 8343386 VITROS DGXN Slides quantitatively measure digoxi...
Medical Devices·24,857 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products TBIL Slides packaged as 300 slides/pack catalog number 8159931 VITROS TBIL Slides quantitatively measure total...
Medical Devices·175,689 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CHE Slides packaged as 300 slides/pack catalog number 1914605 and packaged as 90 slides/pack catalog number 800...
Medical Devices·11,135 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products LIPA Slides packaged as 300 slides/pack catalog number 1668409 and packaged as 90 slides/pack catalog number 82...
Medical Devices·62,039 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products BuBc Slides packaged as 300 slides/pack catalog number 8383051 and packaged as 90 slides/pack catalog number 16...
Medical Devices·74,792 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Ca Slides packaged as 300 slides/pack catalog number 1450261 VITROS Ca Slides quantitatively measure calcium (...
Medical Devices·231,112 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products ECO2 Slides packaged as 300 slides/pack catalog number 8262396 VITROS ECO2 Slides quantitatively measure total...
Medical Devices·205,534 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products UPRO Slides packaged as 90 slides/pack catalog number 6800120 VITROS UPRO Slides quantitatively measure protei...
Medical Devices·31,395 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products URIC Slides packaged as 300 slides/pack catalog number 1943927 VITROS URIC Slides quantitatively measure uric ...
Medical Devices·85,646 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products THEO Slides packaged as 300 slides/pack catalog number 8301764 and packaged as 90 slides/pack catalog number 13...
Medical Devices·7,926 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CREA Slides packaged as 300 slides/pack catalog number 6802584 VITROS CREA Slides quantitatively measure creat...
Medical Devices·364,752 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Fe Slides packaged as 300 slides/pack catalog number 1515808 and packaged as 90 slides/pack catalog number 1924...
Medical Devices·37,525 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CRP Slides packaged as 90 slides/pack catalog number 8097990 VITROS CRP Slides quantitatively measure C-reacti...
Medical Devices·86,522 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CK-MB Slides packaged as 300 slides/pack catalog number 8058232 and packaged as 90 slides/pack catalog number 8...
Medical Devices·28,739 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4) 6802413 Product Usage: The C...
Diagnostic Devices·0 affected·Jun 6, 2013
RecallFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, Product Usage: For in vitro diagnostic use...
Diagnostic Devices·4,257 affected·May 9, 2013
Medium RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596, Product Usage: For in vitro diagnostic use o...
Diagnostic Devices·236,364 affected·May 9, 2013
High RiskFDA
Ortho-clinical Diagnostics
ORTHO¿ Assay Software (OAS) Server, Catalog # 6842840 Usage: The ORTHO¿ Summit System (OSS) is a modular, integrated system for use w...
Diagnostic Devices·31 affected·May 6, 2013
High RiskFDA
Ortho-clinical Diagnostics
1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refurbished (product code 6801890) Pro...
Diagnostic Devices·101 affected·May 6, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5600 Integrated System (product code 6802413) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qua...
Diagnostic Devices·381 affected·May 6, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445) Product Usage: For use in the in vitro quant...
Diagnostic Devices·69 affected·May 6, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the in vitro quantitative, semi-quantitative, an...
Diagnostic Devices·98 affected·May 6, 2013
RecallFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK For use ...
Diagnostic Devices·3,019 affected·Apr 3, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine ...
Diagnostic Devices·478 affected·Apr 1, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. Intended for use in the measurement of a vari...
Medical Devices·58 affected·Feb 7, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5600 Integrated System, Product Code 6802413. Intended for use in the measurement of a variety of chemistry analytes.
Medical Devices·775 affected·Feb 7, 2013
High RiskFDA
Ortho-clinical Diagnostics
Ortho Clinical Diagnostics VITROS¿ Chemistry Products Vapor Adsorption Cartridge REF/CAT No. 680 0100. VITROS¿ Vapor Adsorption Cartrid...
Diagnostic Devices·15,891 affected·Dec 13, 2012
RecallFDA
Ortho-clinical Diagnostics
VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantita...
Diagnostic Devices·1,464 affected·Nov 1, 2012
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5600 Integrated System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variet...
Medical Devices·1,387 affected·May 21, 2012
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety...
Medical Devices·77 affected·May 21, 2012
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of anal...
Medical Devices·2,044 affected·May 21, 2012