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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 381–400 of 970 recalls

Siemens Healthcare Diagnostics, Inc.: Dimension Vista High Sensitivity Troponin I (TNIH) Flex r...

Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples

FDAJul 24, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Ortho Clinical Diagnostics: VITROS XT3400 Chemistry System, Product code 6844458

When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.

FDAJul 20, 2020Nationwide• Ortho Clinical Diagnostics

Ortho Clinical Diagnostics: VITROS XT7600 Integrated System, Product code 6844461

When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.

1...18 192021 22...49

Page 20 of 49Next

FDA

Jul 20, 2020

Nationwide

• Ortho Clinical Diagnostics

Ortho Clinical Diagnostics: VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV...

The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures.

FDAJul 17, 2020Nationwide• Ortho Clinical Diagnostics

Ortho Clinical Diagnostics: VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS ...

The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures.

FDAJul 17, 2020Nationwide• Ortho Clinical Diagnostics

Ortho-Clinical Diagnostics: VITROS Chemistry Products BuBc Slides - in vitro diagnost...

Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides

FDAJul 13, 2020Nationwide• Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics: VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is no...

Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides

FDAJul 13, 2020Nationwide• Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics: VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In...

Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides

FDAJul 13, 2020Nationwide• Ortho-Clinical Diagnostics

Siemens Healthcare Diagnostics, Inc.: DCA Vantage Handheld Barcode Scanner - Zebra Model - Mode...

If DCA Vantage Analyzer is configured to run Code 39 with check digit, the scanner is not confirming the integrity of read barcode data using the check digit. Also, if DCA Vantage Analyzer is configured to run Code 39 with check digit and an operator erroneously scans a Code 39 barcode without a check digit, the scanner incorrectly sends the code and the last character is removed.

FDAJun 30, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Chembio Diagnostics, Inc: Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromat...

FDA revocation of the Emergency Use Authorization due to performance issues

FDAJun 18, 2020Nationwide• Chembio Diagnostics, Inc

Chembio Diagnostics, Inc: Chembio DPP Micro Reader for use with the DPP COVID-19 Ig...

FDA revocation of the Emergency Use Authorization due to performance issues

FDAJun 18, 2020Nationwide• Chembio Diagnostics, Inc

Chembio Diagnostics, Inc: Chembio DPP Micro Reader II for use with the DPP COVID-19...

FDA revocation of the Emergency Use Authorization due to performance issues

FDAJun 18, 2020Nationwide• Chembio Diagnostics, Inc

Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry Calibrator

Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH.

FDAJun 5, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH Chemistry Calibrator

Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH.

FDAJun 5, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

LONGHORN VACCINES AND DIAGNOSTIC 2 Bethesda Metro Cente: PrimeStore Molecular Transport Medium (PS-MTM), Model Num...

The tubes may have been delivered to some users without labels. Users may not be able to identify the tubes without these labels. If samples stored or transported in tubes are tested on certain systems or come into contact with bleach they can produce cyanide gas. The solution in these tubes contains guanidine thiocynate and may put laboratory personnel at risk of exposure to cyanide gas when it comes into contact with bleach or reagents containing bleach.

FDAJun 3, 2020Nationwide• LONGHORN VACCINES AND DIAGNOSTIC 2 Bethesda Metro Cente

Siemens Healthcare Diagnostics Inc: RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC...

The scanner is not confirming the integrity of read barcode data using the check-digit when reading Code 39 barcodes.

FDAMay 27, 2020Nationwide• Siemens Healthcare Diagnostics Inc

Ortho Clinical Diagnostics: VITROS 3600 Immunodiagnostic System Software Versions 3.3...

Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances

FDAMay 20, 2020Nationwide• Ortho Clinical Diagnostics

Ortho Clinical Diagnostics: VITROS XT 7600 Integrated System Software Versions 3.5.1 ...

Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances

FDAMay 20, 2020Nationwide• Ortho Clinical Diagnostics

Ortho Clinical Diagnostics: VITROS 5600 Integrated System Software Versions 3.3.3 and...

Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances

FDAMay 20, 2020Nationwide• Ortho Clinical Diagnostics

Siemens Healthcare Diagnostics Inc.: Siemens IMMULITE 2000 Immunoassay System - In vitro Chemi...

Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenance potentially causing liquid waste can leak onto the floor, creating a slip and fall hazard

FDAMay 15, 2020Nationwide• Siemens Healthcare Diagnostics Inc.