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FDAFebruary 28, 2023device

BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack

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

The hazard

APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.

What to do

FDA enforcement status: Ongoing

Brands named

bio rad laboratoriesbiobio rad

UPCs

847865000666

Recall history

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

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