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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