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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

1000

Past Year

303

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 1101–1120 of 4747 recalls

Siemens Healthcare Diagnostics, Inc: Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN ...

Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.

FDASep 22, 2021Nationwide• Siemens Healthcare Diagnostics, Inc

AirDuo Digihaler 55/14 (Teva) – Subpotent Salmeterol (2021)

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

Class IIModerate

FDASep 22, 2021Nationwide• Teva Pharmaceuticals USA

AirDuo Digihaler 232/14 (Teva) – Subpotent Salmeterol (2021)

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

Class II

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Moderate

FDASep 22, 2021Nationwide• Teva Pharmaceuticals USA

AirDuo Digihaler 113/14 (Teva) – Subpotent Salmeterol (2021)

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

Class IIModerate

FDASep 22, 2021Nationwide• Teva Pharmaceuticals USA

AirDuo Digihaler 232/14 (Teva) – Subpotent Salmeterol (2021)

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

Class IIModerate

FDASep 22, 2021Nationwide• Teva Pharmaceuticals USA

AirDuo Digihaler 113/14 (Teva) – Subpotent Salmeterol (2021)

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

Class IIModerate

FDASep 22, 2021Nationwide• Teva Pharmaceuticals USA

Siemens Healthcare Diagnostics, Inc.: Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), S...

The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.

FDASep 20, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP...

The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.

FDASep 20, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.