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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

Randox Laboratories Ltd.: Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range

Agency Publication Date: January 5, 2023
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Affected Products

Product: Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1

GTIN: 05055273204896 Lot Number/Exp. Date: 584LPC 28th Jun 23; 600LPC 28th Nov 23; 611LPC 28th Sep 24;

Lot Numbers:
Number
Product: Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683

GTIN: 05055273204902 Lot Number/Exp. Date: 585LPC 28thJun 23; 601LPC 28th Nov 23; 612LPC 28th Sep 24

Lot Numbers:
Number
Product: Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684

GTIN: 05055273204919 Lot Number/Exp. Date: 586LPC 28th Jun 23; 602LPC 28th Nov 23; 628LPC 28th Dec 24;

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91225
Status: Active
Manufacturer: Randox Laboratories Ltd.
Manufactured In: Ireland
Units Affected: 3 products (146 units US; 115 units; 49 units US)

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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.