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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Siemens Healthcare Diagnostics, Inc.: Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.

Agency Publication Date: April 14, 2022
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Affected Products

Product: Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644

UDI: 00630414220697; Lot Numbers: 211392 211438 211484 211522 211526

Lot Numbers:
Numbers
Product: Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536

UDI: 00630414220505; Lot Numbers: 110027 110060 110065 110091 110113 110129 110137 110161 110170 110208 110224 110234 110235 110262 110265 110273 110286 110315 110330 110347 110360

Lot Numbers:
Numbers
Product: Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637

UDI: 00630414595580; Lot Numbers: 211359 211451

Lot Numbers:
Numbers
Product: Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637

UDI: 00630414287935; Lot Numbers: 110108 110185 110238 110302

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89740
Status: Active
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Manufactured In: United States
Units Affected: 4 products (2,395; 6606; 199; 2158)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.