FDANovember 1, 2022device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

randox laboratoriesrandox

UPCs

05055273203882

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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