FDAFDA · Food and drugs·Recall number Z-1358-2024
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Published April 3, 2024 · Recall initiated: February 15, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Bio-Rad Laboratories
- Distributor
- US Nationwide distribution in the states of PA, SD, TX, FL, MN.
- Lot
- Lot # 64562656 & 64571846/ UDI: 03610521162834
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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