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FDAApril 14, 2022device

BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack

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

The hazard

Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.

What to do

FDA enforcement status: Ongoing

Brands named

bio rad laboratoriesbiobio rad

UPCs

03610520992715

Recall history

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

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