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Ortho-Clinical Diagnostics Recalls
311 recalls on record · August 1, 2012 to September 24, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 14, 2019Medical DevicesFDA
Ortho Clinical Diagnostics recalls VITROS 350 Chemistry System, clinical chemistry analyzer
Hazard: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
August 14, 2019Medical DevicesFDA
Ortho Clinical Diagnostics recalls VITROS 250AT Chemistry System, clinical chemistry analyzer
Hazard: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
August 14, 2019Medical DevicesFDA
Ortho Clinical Diagnostics recalls VITROS 250 Chemistry System, clinical chemistry analyzer
Hazard: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
August 14, 2019Medical DevicesFDA
Ortho Clinical Diagnostics recalls VITROS 250 Chemistry System, clinical chemistry analyzer
Hazard: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
July 10, 2019Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinica
Hazard: Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
July 10, 2019Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 10758750001330) Product Usage: Performs discr
Hazard: Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
July 10, 2019Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) Product Usage: Performs discrete clinic
Hazard: Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
July 10, 2019Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinica
Hazard: Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
May 29, 2019Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in v
Hazard: Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported
May 15, 2019Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For use in the in vitro quantitative, semi-qua
Hazard: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
May 15, 2019Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro quantitative, semi-quantita
Hazard: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
May 15, 2019Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 For use in the in vitro quantitati
Hazard: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
May 15, 2019Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS¿ 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914 For use in the in vitro q
Hazard: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
May 15, 2019Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative,
Hazard: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
May 15, 2019Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 For use in the in vitro
Hazard: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
May 15, 2019Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitati
Hazard: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
May 1, 2019Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrat
Hazard: One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of this, sample dispense errors may lead to incorrect results being reported without an error code to alert the user.
March 20, 2019Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quan
Hazard: Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.
February 27, 2019Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED US
Hazard: Negative bias results when using VITROS VALP Reagent, GEN 25.
February 27, 2019Medical DevicesFDA
Ortho Clinical Diagnostics Inc recalls Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Sy
Hazard: A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.
January 9, 2019Medical DevicesFDA
ORTHO-CLINICAL DIAGNOSTICS recalls VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only. For the quantitative meas
Hazard: The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current Instructions for Use.
January 9, 2019Medical DevicesFDA
ORTHO-CLINICAL DIAGNOSTICS recalls VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro qualitative detection of hepatitis B e antigen
Hazard: The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current Instructions for Use.
January 9, 2019Medical DevicesFDA
ORTHO-CLINICAL DIAGNOSTICS recalls VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to
Hazard: The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current Instructions for Use.
December 26, 2018Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of
Hazard: Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
December 26, 2018Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a va
Hazard: Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
December 26, 2018Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of
Hazard: Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
December 26, 2018Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qu
Hazard: Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
November 28, 2018Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDL
Hazard: VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results
November 14, 2018Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use onl
Hazard: The reagent pack exhibits the potential for an increased frequency of calibration failures.
October 17, 2018Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS 5600 Integrated System- (Refurbished). For use in the in vitro quantitative, semi-quantitative, and qualitative
Hazard: Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.