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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

125

Past Year

16

Class I (Serious)

0

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 1–20 of 125 recalls

Food Panel 3 Allergen (Siemens) – barcode scanning error (2025)

The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.

FDAOct 6, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

3gAllergy IgE Kit (Siemens) – barcode scanning error (2025)

The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.

FDAOct 6, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

IMMULITE 2000 Oak Mix Allergen (Siemens) – barcode scanning error (2025)

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The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.

Moderate

FDAOct 6, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

IMMULITE 2000 PTH Assay (Siemens) – result inaccuracy (2025)

The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples.

FDASep 22, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica CH Protein Test (Siemens) – false result risk (2025)

Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.

FDAAug 11, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

epoc BGEM BUN Test Card (Siemens) – Sodium Bias (2025)

Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L. The maximum bias observed was -14 mmol/L, which occurred at a higher sodium concentration around 150 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing.

FDAJul 7, 2025Nationwide• Siemens Healthcare Diagnostics Inc

RAPIDPoint 500 Wash Cartridge (Siemens) – Manufacturing Error (2025)

Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, pH, Chloride, pCO2, Glucose and Lactate analytes and their derivatives. Four complaints were filed related to this event that led to Siemens Healthcare Diagnostics identifying an error in the manufacturing process and initiated corrective actions. Use of the affected device may result in errors during QC which could lead to a delay in patient treatment. If bias generated from this issue is not caught during QC erroneous results may cause temporary or medically reversible adverse health consequences to patients.

FDAJun 26, 2025Nationwide• Siemens Healthcare Diagnostics Inc

ADVIA Calibrator (Siemens Healthcare) – Platelet Value Error (2025)

Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.

FDAJun 4, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

ADVIA 3-in-1 Control (Siemens Healthcare) – Platelet Value Error (2025)

Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.

FDAJun 4, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica CH Diluent (Siemens) – Contamination Risk (2025)

Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride.

FDAMay 22, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica Homocysteine Calibrator (Siemens) – Reference Interval (2025)

Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.

FDAApr 15, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

ADVIA Centaur Calibrator (Siemens) – Reference Interval (2025)

Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.

FDAApr 15, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

Stratus CS Cardiac Troponin Test (Siemens) – Potential Test Issue (2025)

Laceration Risk

Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma by removal. The reason for the recall is an increased occurrence of random non-repeatable false positive cardiac Troponin l(cTnI) results at any point during the TestPaks shelf life when using the Stratus CS cTnI Acute Care Testpak.

FDAMar 31, 2025Nationwide• Siemens Healthcare Diagnostics Inc

epoc BGEM BUN Test Card (Siemens) – pH result discrepancy (2025)

The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.

FDAMar 19, 2025Nationwide• Siemens Healthcare Diagnostics Inc

epoc BGEM Crea Test Card (Siemens) – pH result discrepancy (2025)

The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.

FDAMar 19, 2025Nationwide• Siemens Healthcare Diagnostics Inc

Atellica CH CRP (Siemens) – software flagging error (2025)

Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.

FDAMar 11, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

Epoc NXS Host (Siemens) – Software Malfunction (2024)

Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by the device if the user of the device does not ensure verification of the correct patient name. The software malfunction has the potential to impact patient safety via misdiagnosis and/or mistreatment by a clinician if the wrong patient information is saved with the test result from the subject device.

FDANov 22, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Magnesium Flex Reagent Cartridge (Siemens) – Lot Quality Issue (2024)

Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista Total Magnesium (MG) Flex Reagent Cartridges (lots 24057BB and 24064BC) due to the potential for falsely low measurements of magnesium in plasma. Because the error is intermittent, existing quality control procedures may not recognize that a patients results are incorrect, and the results may be reported out

FDANov 12, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica CI Analyzer (Siemens) – Diluent Volume Issue (2024)

Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI Analyzer, potentially leading to the IMT Diluent being empty while still displaying that volume is remaining. In this case Sodium (Na), Potassium (K) and Chloride (Cl) test results may be falsely elevated. Quality Control materials demonstrate the same behavior.

FDANov 4, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica B2M Test (Siemens) – Result Accuracy Issue (2024)

Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH 2-Microglobulin (B2M) reagent.

FDAOct 21, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.