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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:54 PM UTC

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