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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.
September 2, 2020Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL
Hazard: Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
August 19, 2020Medical DevicesFDA
Ortho Clinical Diagnostics recalls VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usa
Hazard: The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures.
August 19, 2020Medical DevicesFDA
Ortho Clinical Diagnostics recalls VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage:
Hazard: The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures.
July 8, 2020Medical DevicesFDA
Ortho Clinical Diagnostics recalls VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758
Hazard: Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
July 8, 2020Medical DevicesFDA
Ortho Clinical Diagnostics recalls VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifi
Hazard: Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
July 8, 2020Medical DevicesFDA
Ortho Clinical Diagnostics recalls VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 1075875000
Hazard: Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
July 8, 2020Medical DevicesFDA
Ortho Clinical Diagnostics recalls VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103
Hazard: Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
July 8, 2020Medical DevicesFDA
Ortho Clinical Diagnostics recalls VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 1075875
Hazard: Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
June 24, 2020Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage: For in vit
Hazard: Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
June 24, 2020Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitr
Hazard: Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
June 24, 2020Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Produ
Hazard: Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
June 24, 2020Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Prod
Hazard: Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
May 20, 2020Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - P
Hazard: The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.
May 20, 2020Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 -
Hazard: The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.
May 6, 2020Medical DevicesFDA
Ortho Clinical Diagnostics recalls VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
Hazard: The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.
February 19, 2020Medical DevicesFDA
Ortho Clinical Diagnostics Inc recalls VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and
Hazard: Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2
January 1, 2020Medical DevicesFDA
Ortho Clinical Diagnostics Inc recalls Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium
Hazard: Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 days.
January 1, 2020Medical DevicesFDA
Ortho Clinical Diagnostics Inc recalls 7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed
Hazard: Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 days
November 13, 2019Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered for
Hazard: Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
November 13, 2019Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain
Hazard: Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
November 13, 2019Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents
Hazard: Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
August 14, 2019Medical DevicesFDA
Ortho-Clinical Diagnostics recalls VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively me
Hazard: Potentially Biased Results using VITROS Chemistry Products GLU Slides
August 14, 2019Medical DevicesFDA
Ortho Clinical Diagnostics recalls VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
Hazard: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
August 14, 2019Medical DevicesFDA
Ortho Clinical Diagnostics recalls VITROS 5,1 FS 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 5,1 FS 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 4600 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 4600 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 5600 Integrated System, clinical chemistry analyzer
Hazard: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
August 14, 2019Medical DevicesFDA
Ortho Clinical Diagnostics recalls VITROS 5600 Integrated System, clinical chemistry analyzer
Hazard: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
August 14, 2019Medical DevicesFDA
Ortho Clinical Diagnostics recalls VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
Hazard: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System