Randox Laboratories Ltd.: Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133 or FR4030 on the RX instruments testing order. Can lead to an elevation in Quality Control and Patient results of up to +13% for lgA and +51% for lgM respectively, which may lead to a delay in running patient samples or erroneous elevated test results

Agency Publication Date: December 3, 2022

Affected Products

Product: IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832

GTIN: 05055273203882 All lots

Product: IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834

GTIN: 05055273204001 All lots

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91097

Status: Resolved

Manufacturer: Randox Laboratories Ltd.

Manufactured In: Ireland

Units Affected: 2 products (20 kits US in total)

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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

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Medium RiskFDA Device