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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

242

Past Year

Class I (Serious)

Most Recent

Oct 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 161–180 of 242 recalls

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.: 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.: Dimension Vista Total Bilirubin Flex reagent cartridge ...

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

FDA

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Page 9 of 13Next

Feb 13, 2020

Nationwide

• 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.: 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.

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(...

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.

Siemens Healthcare Diagnostics, Inc.: Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 0063...

A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.

FDAJan 6, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, S...

Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.

FDADec 20, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520

There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.

FDADec 18, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11...

FDADec 18, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN...

FDADec 18, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SM...

FDADec 18, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH High Sensitivity C-Reactive Protein (HsCRP) C...

Atellica CH: The Atellica CH High Sensitivity CReactive Protein Calibrator (hsCRP CAL) is for in vitro diagnostic use in calibrating the hsCRP assay using the Atellica CH Analyzer.

FDANov 19, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry CardioPhase High Sensitivity C-Reactive P...

Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-DA470/IFCC), which is causing a high bias on QC and patient sample recovery.

FDANov 19, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

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

On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Multisensor Technology (IMT) system fluids (Standard A (Std A) and Standard B (Std B)) for Sodium (Na), Potassium (K), and Chloride (Cl), the system will translate the decimal point separators to commas. This will result in invalid concentration values for the fluids, therefore the system will utilize default nominal values instead of lot specific IMT fluid concentration values for calculation of the calibrations and results for the Na, K, and Cl methods.

FDAOct 11, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH 930 Analyzer

Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.

FDASep 23, 2019AL, AZ, AR +33 more• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19...

Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2

FDAAug 15, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.