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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 61–80 of 970 recalls

VITROS CRP Slides (Ortho-Clinical) – Result Bias Issue (2024)

May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher than 90 mg/L. User no way to know if the sample has to be diluted to measure again.

Moderate

FDAOct 11, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

IMMULITE 2000 PSA Assay (Siemens) – High-Dose Hook Effect Issue (2024)

The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructions for Use (IFU).

Moderate

FDASep 30, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

AVOXimeter 1000E (Accriva) – Calibration Value Inaccuracy (2024)

Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual results, which may lead to patient care mismanagement requiring medical intervention.

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Moderate

FDASep 27, 2024AZ• Accriva Diagnostics, Inc.

epoc BGEM BUN Test Card (Siemens) – Sodium Bias (2024)

Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing. One customer complaint has been associated with this issue. No adverse events have been reported. All affected lots have recently expired before the issuance of the recall.

Low

FDASep 24, 2024Nationwide• Siemens Healthcare Diagnostics Inc

A1CNow+ HbA1c System (PTS Diagnostics) – Code Mismatch Problem (2024)

The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system box. Use of cartridges and analyzers with non-matching codes may result in inaccurate test results as components within each lot number are meant to be used together, and not mixed between lots. Therefore, the test results may possibly lead to Hemoglobin A1C positive or negative bias results. While the product is for monitoring only, over recovery with a higher than accurate value can be an indication for increased therapy; such as physical activity, weight reduction, meal management, pharmaceutical therapy.

FDASep 18, 2024Nationwide• Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.

NxTAG Respiratory Panel (Luminex) – Target Detection Issue (2024)

Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that present positivity for another target, leading to an erroneous co-infection result, can potentially result in hMPV false positives.

FDASep 5, 2024Nationwide• Luminex Molecular Diagnostics Inc

Atellica IM aTPO Assay (Siemens) – Result Bias (2024)

Laceration Risk

Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.

FDAAug 21, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

ADVIA Centaur aTPO Assay (Siemens) – Result Bias (2024)

Laceration Risk

Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.

FDAAug 21, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Creatine Kinase Assay (Roche) - Calibration Abnormality (2024)

Creatine Kinase (CK) Assay Abnormal calibrations on the cobas c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and misdiagnosis.

FDAAug 15, 2024Nationwide• Roche Diagnostics Operations, Inc.

ADVIA Chemistry Microalbumin (Siemens) - Performance Claim Issue (2024)

Atellica CH Microalbumin_2 (ALB_2) and the ADVIA Chemistry Microalbumin_2 (ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated in the Instructions for Use (IFU) on the Atellica CH, Atellica CI Analyzers, ADVIA 1800 Chemistry Systems, ADVIA 2400 Chemistry Systems, and ADVIA Chemistry XPT Systems, may result in erroneously depressed microalbumin patient results.

FDAAug 15, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica CH Microalbumin (Siemens) - Performance Claim Issue (2024)

FDAAug 15, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

FilmArray 2.0 Instrument (BioFire) - Calibration Equipment Problem (2024)

Salmonella

Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA.

FDAAug 7, 2024Nationwide• BioFire Diagnostics, LLC

FilmArray Torch Module (BioFire) - Calibration Equipment Problem (2024)

Salmonella

FDAAug 7, 2024Nationwide• BioFire Diagnostics, LLC

Dimension Vista TBIL Reagent (Siemens) – Testing Limitation (2024)

During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. There was an issue with the filling line which led to some wells to underfill in lot 23206BA. Calibrator, quality control (QC) and patient results could have been impacted.

FDAJul 30, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

ADVIA Chemistry UCFP (Siemens) – Quality Control Bias (2024)

The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.

FDAJul 29, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica CH UCFP (Siemens) – Quality Control Bias (2024)

The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.

FDAJul 29, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use i... (Siemens Healthcare Diagnostics, Inc.) – positive bias for some samples around... (2024)

Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.

FDAJul 26, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use ... (Siemens Healthcare Diagnostics, Inc.) – positive bias for some samples around... (2024)

FDAJul 26, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica IM CA 19-9 (Siemens) – Test Result Bias (2024)

FDAJul 26, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic ... (Siemens Healthcare Diagnostics, Inc.) – positive bias for some samples around... (2024)

FDAJul 26, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.