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Bio-Rad Laboratories recalls Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Recalled April 3, 2024 · FDA recall Z-1358-2024 · Bio-Rad Laboratories
Hazard
Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values. · FDA Class II
Units
33 units
Sold at
US Nationwide distribution in the states of PA, SD, TX, FL, MN.
Description
Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
Product
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Manufacturer(s)
Bio-Rad Laboratories
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →