Reported Apr 3, 2024 · Ongoing
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Bio-Rad Laboratories
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bio-Rad Laboratories · 5731 W Las Positas Blvd · Pleasanton, CA · 94588-4084
Is this the product you have?
- Bio-Rad
- REF12005660, QXDx BCR-ABL %IS Kit
- Lot codes and dates
- Lot # 64562656 & 64571846/
- UDI03610521162834
- Amount recalled
- 33 units
Where it was sold
Why it was recalled
Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
This product could cause temporary or reversible health problems — stop using it.
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