FDASeptember 17, 2021device

BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack.

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

The hazard

Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure.

What to do

FDA enforcement status: Ongoing

Brands named

bio rad laboratoriesbiobio rad

UPCs

03610520652770

Recall history

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

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