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FDAFebruary 15, 2024device

Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit

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

The hazard

Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.

What to do

FDA enforcement status: Ongoing

Brands named

bio rad laboratoriesbiobio rad

UPCs

03610521162834

Recall history

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

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