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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

Leica Microsystems, Inc.: Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up to the expiry date on the product labeling. ; Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the expiry date on the product labeling.

Agency Publication Date: June 1, 2016
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Affected Products

Product: Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation.

1ml size Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) with lot numbers 6036120, 6032345 and 6023543.

Lot Numbers:
numbers
Product: Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.

1ml size Novocastr Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) with lot numbers 6032734, 6033766, 6037153 and 6039088.

Lot Numbers:
numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 73802
Status: Resolved
Manufacturer: Leica Microsystems, Inc.
Manufactured In: United States
Units Affected: 2 products (270 units; 90 Units)

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.