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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

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 281–300 of 475 recalls

Siemens Healthcare Diagnostics, Inc.: Dimension Vista Enzymatic Creatinine, Siemens Material Nu...

The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.

FDAMay 4, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Enzymatic Creatinine, Siemens Material Number 1...

The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.

FDAMay 4, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Mate...

The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.

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FDAMay 4, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH Fructosamine Reagent (FRUC), Siemens Material...

The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.

FDAMay 4, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH Enzymatic Creatinine_2, Siemens Material Numb...

The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.

FDAMay 4, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material ...

The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.

FDAMay 4, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Diagnostica Stago, Inc.: STA - Deficient VIII, Product Code: 00725. STA - Deficie...

A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments, clotting times will be shortened that may cause factor VIII levels reported to be falsely increased

FDAMar 4, 2020Nationwide• Diagnostica Stago, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH 930 Analyzer, Siemens Material Number 1106700...

Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or Auto-Dilution results may generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the reagent pack is not calibrated.

FDAFeb 27, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Materi...

The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.

FDAFeb 14, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic ...

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

FDAFeb 13, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Total Bilirubin Flex reagent cartridge -In vit...

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

FDAFeb 13, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Vista Total Bilirubin Flex reagent cartridge ...

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

FDAFeb 13, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (...

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

FDAFeb 13, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic f...

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

FDAFeb 13, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 ...

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

FDAFeb 13, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Roche Diagnostics Operations, Inc.: Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: th...

The firm has received an increased number of complaints concerning non-reproducible elevated results ("high flyers") for one lot of Elecsys CA 19-9 reagent, which may affect clinical interpretation.

FDAFeb 7, 2020Nationwide• Roche Diagnostics Operations, Inc.

Siemens Healthcare Diagnostics, Inc.: IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(...

Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as pre-menopausal when truly post- menopausal. This may lead to delayed initiation of a potentially beneficial drug and/or administration of an unnecessary drug in the treatment for hormone receptor positive advanced or metastatic breast cancer.

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

Siemens Healthcare Diagnostics, Inc.: IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(...

Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as pre-menopausal when truly post- menopausal. This may lead to delayed initiation of a potentially beneficial drug and/or administration of an unnecessary drug in the treatment for hormone receptor positive advanced or metastatic breast cancer.

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

Siemens Healthcare Diagnostics, Inc.: Atellica CH Reaction Ring Segment, SMN 11099326, UDI 0063...

Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette, which may falsely elevate or depress sample results.

FDAJan 12, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Roche Diagnostics Operations, Inc.: cobas infinity core, Material No. 7154003001. The device ...

Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen.

FDAJan 7, 2020AL, AK, CA +17 more• Roche Diagnostics Operations, Inc.