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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

1000

Past Year

304

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 601–620 of 4747 recalls

epoc NXS Host Blood Analysis (Siemens) – software error (2023)

Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When the results are run on the epoc NXS Host and Delete Blood Tests feature is enabled, the results that are generated at the time of testing are correct; however, when this issue occurs, results that are printed, saved and/or transferred to a data manager, may include unselected analytes that are from a previous patient or QC test. The worst possible outcome may result in a failure to diagnose hyperkalemia, due to an erroneous depressed potassium level or inappropriate treatment to hyperglycemia due to erroneous glucose reading.

FDAOct 19, 2023Nationwide• Siemens Healthcare Diagnostics Inc

Oxybutynin Chloride 10mg Tablets (Zydus) – Dissolution Failure (2023)

Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.

Class IIModerate

FDAOct 19, 2023Nationwide• Zydus Pharmaceuticals (USA) Inc

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Oxybutynin Chloride 15mg Tablets (Zydus) – Dissolution Failure (2023)

Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.

Class IIModerate

FDAOct 19, 2023Nationwide• Zydus Pharmaceuticals (USA) Inc

Oxybutynin Chloride 5mg Tablets (Zydus) – Dissolution Failure (2023)

Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.

Class IIModerate

FDAOct 19, 2023Nationwide• Zydus Pharmaceuticals (USA) Inc

BIOFIRE Blood Culture Panel (BioFire) – control panel problem (2023)

Routine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control panel/instrument characteristic changes, that lead C. tropicalis to be amplified in some portion of test runs, but then it's reported as "Not Detected" because the assay amplicon Tm is outside the acceptable limit assigned for calling positive results.

FDAOct 17, 2023Nationwide• BioFire Diagnostics, LLC

FilmArray TORCH (BioFire) – power switch risk (2023)

Due to an increased risk of degradation of the power entry switch resulting from arcing inside of the power switch that may result in carbon build-up on the switch contacts. The carbon build-up may lead to excess heating inside of the power switch, subsequently leading to deformation of the power switch case. The deformation can create an opportunity for a power switch electrical short. In addition to an electrical short, deformation may result in an open circuit causing the power switch to fail. This event would only occur after the product is in use.

FDAOct 17, 2023Nationwide• BioFire Diagnostics, LLC

VITROS XT 7600 System (Ortho-Clinical) – Software Issues (2023)

During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.

FDAOct 10, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

Zemits NDPrime Laser (Advance-Esthetic) – Radiation Control Violation (2023)

Advance-Esthetic LLC failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standards and certification. This Recall provides correction by the firm regarding Zemits NdPrime Yag Tattoo Removal Laser. The product requires update or is missing the following in part: remote interlock connector, safety interlocks, manual reset mechanism, beam attenuator, tests for determination of compliance, certification, class IV designation and warning, labels, and labeling.

FDAOct 9, 2023Nationwide• Advance-Esthetic LLC