FDAFebruary 21, 2023device

BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD

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

The hazard

Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positives.

What to do

FDA enforcement status: Ongoing

Brands named

bio rad laboratoriesbiobio rad

UPCs

00847865000857

Recall history

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

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