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Accriva Diagnostics, Inc.

Accriva Diagnostics, Inc. Recalls

All product recalls associated with Accriva Diagnostics, Inc..

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Recall Summary

Total Recalls

475

Past Year

37

Class I (Serious)

6

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 41–60 of 475 recalls

VerifyNow P2Y12 Platelet Test (Accriva) – Market Clearance Issue (2024)

Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent inhibition formula in the notice to manually calculate the percentage of platelet aggregation inhibition for a given patient receiving drug treatment with P2Y12 receptor inhibitor.

FDADec 2, 2024Nationwide• Accriva Diagnostics, Inc.

Epoc NXS Host (Siemens) – Software Malfunction (2024)

Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by the device if the user of the device does not ensure verification of the correct patient name. The software malfunction has the potential to impact patient safety via misdiagnosis and/or mistreatment by a clinician if the wrong patient information is saved with the test result from the subject device.

FDANov 22, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

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Magnesium Flex Reagent Cartridge (Siemens) – Lot Quality Issue (2024)

Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista Total Magnesium (MG) Flex Reagent Cartridges (lots 24057BB and 24064BC) due to the potential for falsely low measurements of magnesium in plasma. Because the error is intermittent, existing quality control procedures may not recognize that a patients results are incorrect, and the results may be reported out

Moderate

FDANov 12, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica CI Analyzer (Siemens) – Diluent Volume Issue (2024)

Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI Analyzer, potentially leading to the IMT Diluent being empty while still displaying that volume is remaining. In this case Sodium (Na), Potassium (K) and Chloride (Cl) test results may be falsely elevated. Quality Control materials demonstrate the same behavior.

FDANov 4, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Atellica Cuvette Segment (Siemens) – Manufacturing Defect (2024)

A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the cuvette segment have a potential for imprecision and erroneously depressed or elevated QC and patient results for seven (7) analytes: Ammonia, Acetaminophen, Alanine Aminotransferase (ALT), Hemoglobin A1c, Creatinine Kinase (CK), Cystatin C, and Salicylate.

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

Atellica B2M Test (Siemens) – Result Accuracy Issue (2024)

Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH 2-Microglobulin (B2M) reagent.

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

Cobas HCYS Test (Roche) – Calibration Signal Issue (2024)

Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)

FDAOct 17, 2024FL, IN, IA +5 more• Roche Diagnostics Operations, Inc.

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.

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).

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.

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.

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

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.

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.

Atellica CH 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.

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.

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.

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.