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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

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 301–320 of 475 recalls

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.

Clinical Diagnostic Solutions, Inc.: Medonic M-Series Hematology Analyzer M16S BD ABR US Pro...

A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspiration needle.

FDAJan 2, 2020Nationwide• Clinical Diagnostic Solutions, 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.

1...14 151617 18...24

Page 16 of 24Next

FDA

Dec 20, 2019

Nationwide

• Siemens Healthcare Diagnostics, Inc.

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

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.: ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SM...

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.: Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520

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

Ortho Clinical Diagnostics Inc: VITROS Chemistry Products Calibrator Kit 2- IVD calibrat...

Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2

FDADec 16, 2019Nationwide• Ortho Clinical 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 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.

Diagnostica Stago, Inc.: STA UNICALIBRATOR (ref. 00675)

A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.

FDANov 18, 2019AL, AK, AZ +39 more• Diagnostica Stago, Inc.

Diagnostica Stago, Inc.: STA SYSTEM CONROL N + P (ref. 00678)

FDANov 18, 2019AL, AK, AZ +39 more• Diagnostica Stago, Inc.

Roche Diagnostics Operations, Inc.: Elecsys Anti-HAV IgM assay-for the in vitro qualitative d...

Current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneous Border Area setting, (1.0 1.00) instead of (0.90 1.10).

FDAOct 28, 2019Nationwide• Roche Diagnostics Operations, Inc.

Ortho Clinical Diagnostics Inc: Urine Electrolyte Diluent, Product Code: 1112352 - Produc...

Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 days.

FDAOct 14, 2019Nationwide• Ortho Clinical Diagnostics Inc

Ortho Clinical Diagnostics Inc: 7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Pr...

Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 days

FDAOct 14, 2019Nationwide• Ortho Clinical 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.

Roche Diagnostics Operations, Inc.: Cobas infinity central lab / cobas infinity core license-...

Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a CommServer Driver - Incorrect Alarm Mapping

FDAOct 8, 2019Nationwide• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: Roche Homocysteine-In vitro test for the quantitative det...

Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules

FDAOct 4, 2019Nationwide• Roche Diagnostics Operations, 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.

Roche Diagnostics Operations, Inc.: Cobas c Bilirubin Total Gen.3 Catalog Number: 0579541919...

Due to low Quality Control recovery and invalid Calibration.

FDASep 11, 2019Nationwide• Roche Diagnostics Operations, Inc.