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Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc. Recalls

All product recalls associated with Siemens Healthcare 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 41–60 of 970 recalls

Atellica CH CRP (Siemens) – software flagging error (2025)

Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.

Low

FDAMar 11, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

Pacific Hemostasis Thromboplastin-D (Fisher Diagnostics) – Incorrect ISI Label (2025)

The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.

Low

FDAMar 6, 2025PA• Fisher Diagnostics

ID NOW Influenza A/B Test (Abbott) – High Invalid Rate (2025)

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

Moderate

FDAMar 4, 2025Nationwide

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• Abbott Diagnostics Scarborough, Inc.

ID NOW RSV Test (Abbott) – High Invalid Rate (2025)

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

Moderate

FDAMar 4, 2025Nationwide• Abbott Diagnostics Scarborough, Inc.

ID NOW COVID-19 Test (Abbott) – High Invalid Rate (2025)

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

Moderate

FDAMar 4, 2025Nationwide• Abbott Diagnostics Scarborough, Inc.

FilmArra Pneumonia Panel (BioFire) – Test Result Reliability (2025)

Increased risk of control failures and false negative test results with multiplexed nucleic acid test.

Moderate

FDAFeb 27, 2025Nationwide• BioFire Diagnostics, LLC

VITROS XT 7600 System (Ortho-Clinical) – Reagent Pack Notification Issue (2024)

The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.

Moderate

FDADec 19, 2024Nationwide• Ortho-Clinical Diagnostics, INc.

VITROS 5600 Integrated System (Ortho-Clinical) – Reagent Pack Notification Failure (2024)

The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.

Moderate

FDADec 19, 2024Nationwide• Ortho-Clinical Diagnostics, INc.

VITROS 3600 Immunodiagnostic System (Ortho-Clinical) – Software Notification Failure (2024)

The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.

Moderate

FDADec 19, 2024Nationwide• Ortho-Clinical Diagnostics, INc.

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.

Moderate

FDADec 2, 2024Nationwide• Accriva Diagnostics, Inc.

Grecian Delight Tzatziki Sauce (Grecian Delight) – Salmonella Risk (2024)

Salmonella

potential for salmonella

Class IHigh

FDADec 2, 2024AR, CA, CO +24 more• Grecian Delight/Kronos

Nick The Greek Yogurt (Grecian Delight) – Salmonella Potential (2024)

Salmonella

potential for salmonella

Class IHigh

FDADec 2, 2024AR, CA, CO +24 more• Grecian Delight/Kronos

US Foods Chef's Line Greek Yogurt Tzatziki (Grecian Delight) – Salmonella Risk (2024)

Salmonella

potential for salmonella

Class IHigh

FDADec 2, 2024AR, CA, CO +24 more• Grecian Delight/Kronos

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.

High

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

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.

Low

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

Tempus LS-Manual Defibrillator (Remote Diagnostic) – incorrect labeling (2024)

Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.

Low

FDAOct 28, 2024Nationwide• Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom

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.

Moderate

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.

Moderate

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)

Moderate

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