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Ortho Clinical Diagnostics Inc

Ortho Clinical Diagnostics Inc Recalls

All product recalls associated with Ortho Clinical Diagnostics Inc.

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Recall Summary

Total Recalls

970

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 341–360 of 970 recalls

Ortho Clinical Diagnostics Inc: VITROS Chemistry Products TP Slides- IVD measure total pr...

Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides

FDADec 15, 2020Nationwide• Ortho Clinical Diagnostics Inc

Ortho Clinical Diagnostics Inc: VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Sl...

VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference

FDADec 11, 2020Nationwide• Ortho Clinical Diagnostics Inc

Roche Diagnostics Operations, Inc.: Roche cobas pro integrated solutions (cobas pro ISE, coba...

Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.

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FDADec 8, 2020Nationwide• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: Roche cobas 8000 modular analyzer series (i.e., cobas 800...

FDADec 8, 2020Nationwide• Roche Diagnostics Operations, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1300 Analyzer - In vitro diagnostic testing o...

Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

FDADec 2, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH 930 Analyzer - In vitro diagnostic testing of...

Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

FDADec 2, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1600 Analyzer - In vitro diagnostic testing o...

Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

FDADec 2, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Roche Diagnostics Operations, Inc.: CoaguChek XS PST Meters- IVD (Patient Self-Testing) measu...

Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results

FDADec 2, 2020Nationwide• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: CoaguChek XS Prof (Professional) Meters- IVD professional...

Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results

FDADec 2, 2020Nationwide• Roche Diagnostics Operations, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product ...

Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonstrate a coefficient of variation (%CV) outside of the performance data for repeatability (within-run) listed in the Instructions For Use (IFU) on some analyzers.

FDANov 23, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Produ...

FDANov 23, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Roche Diagnostics Operations, Inc.: cobas pro integrated solutions -cobas c 503, Analyzer, ch...

During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and lead to inaccurately low results for the affected TDMs (Therapeutic Drug Monitoring).

FDANov 23, 2020FL, GA, IL +1 more• Roche Diagnostics Operations, Inc.

Ortho-Clinical Diagnostics, Inc.: VITROS Automation Solutions, VAS, Catalog Numbers 6844300...

A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to results being associated with the wrong patient sample and potentially lead to inappropriate intervention with the potential for injury to the patient.

FDANov 20, 2020Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: enGen Laboratory Automation System, enGen Track System, C...

FDANov 20, 2020Nationwide• Ortho-Clinical Diagnostics, Inc.

Remote Diagnostic Technologies Ltd. PAVILION C2, ASHWOOD PARK ASHWOOD WAY Basingstoke United Kingdom: Tempus LS - Manual Defibrillator, Model Number: 00-3020 S...

A software error was detected within software version 1.3.4 for the Tempus LS device. When exiting pacer back into manual mode the pacer pulse wave may put the ECG calibration out of calibration. This software error may result in a delay in therapy, as the clinician is not provided an ECG waveform on which a shockable rhythm decision can be made. The device is still able to deliver a manual defibrillation shock.

FDANov 17, 2020Nationwide• Remote Diagnostic Technologies Ltd. PAVILION C2, ASHWOOD PARK ASHWOOD WAY Basingstoke United Kingdom

Roche Diagnostics Operations, Inc.: Tina-quant C-Reactive Protein Gen.3, Catalog number 05172...

Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas c701 and 702 modules. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.

FDANov 6, 2020Nationwide• Roche Diagnostics Operations, Inc.

VEO DIAGNOSTICS, LLC: ACCEL ELISA COVID-19 for the detection of total antibodie...

Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests

FDANov 5, 2020Nationwide• VEO DIAGNOSTICS, LLC

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1300 Analyzer - Product Usage: automated, imm...

Test Definition scanning may reset custom settings to defaults causing falsely low or high results. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values

FDAOct 26, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1600 Analyzer - Product Usage: automated, imm...

Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values

FDAOct 26, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Hardy Diagnostics: Viral Transport Medium, 3ml, Ref: R99, Container type: Tu...

There is a potential for contamination within Viral Transport Media. Use of contaminated Viral Transport Media for the transport of patient specimen may compromise the detection of COVID-19 by the final device used for testing.

FDAOct 23, 2020Nationwide• Hardy Diagnostics