Class II
Medical Device Recall: Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Bio-Rad Laboratories · February 15, 2024
Reason for Recall
Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
Distribution
US Nationwide distribution in the states of PA, SD, TX, FL, MN.
States Affected
NATIONWIDE
Quantity Affected
33 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1358-2024
Status: ongoing
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