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All product recalls associated with Siemens Healthcare Diagnostics, Inc.
Total Recalls
970
Past Year
46
Class I (Serious)
16
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.
Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
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.