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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.: Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result

Agency Publication Date: December 15, 2022
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Affected Products

Product: IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Number (SMN): 10708840 For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.

UDI-DI (01)00630414982939(10)D830(17)20221130; (01)00630414982939(10)D831(17)20221130; (01)00630414982939(10)D832(17)20221130; (01)00630414982939(10)D833(17)20221130. Lot Numbers: D830, D831, D832, D833

Lot Numbers:
Numbers
Product: IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 10380875 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.

UDI:-DI: (01)00630414962269(10)826(17)20221130; (01)00630414962269(10)830(17)20221130; (01)00630414962269(10)831(17)20221130; (01)00630414962269(10)832(17)20221130; (01)00630414962269(10)833(17)20221130. Kit Lots: 826, 830, 831,832, 833

Product: IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.

UDI:-DI: (01)00630414278735(10)565(17)20221130 Kit Lot 565

Lot Numbers:
565

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91164
Status: Active
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Manufactured In: United States
Units Affected: 3 products (1000 kits; 5,193 kits; 560 kits)

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.