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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: N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).

Agency Publication Date: October 14, 2022
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Affected Products

Product: N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297

UDI-DI: 0405686900179VF Lot Number: 153088 Future lots may be impacted by the issue but will then be provided with a corresponding instruction note within the reagent package

Lot Numbers:
Number
Product: N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299

UDI-DI: 0405686900179VF Lot Number: 153083; 153085; 153087A; 153090; 153095B; 153099A; 153004B. Future lots may be impacted by the issue but will then be provided with a corresponding instruction note within the reagent package

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90867
Status: Active
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC
Manufactured In: Spain
Units Affected: 2 products (373 PCK; 10,201 packs)

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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.