Medical device recalls Moderate risk

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

Recall date
February 15, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1358-2024
FDA classification
Class II
Brand / firm
Bio-Rad Laboratories
Sold / distributed
US Nationwide distribution in the states of PA, SD, TX, FL, MN.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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