Randox Laboratories Ltd. recalls IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832

Recall date

November 1, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0362-2023

FDA classification

Class II

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

US Nationwide Distribution: CA, NC, NJ and WV,

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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