Bio-Rad QXDx BCR-ABL diagnostic kit recalled for calibration errors
Bio-Rad Laboratories is recalling a diagnostic test kit due to incorrect calibrations and controls that may produce inaccurate test results. Patients and healthcare providers should contact the manufacturer.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a risk-of-harm diagnostic test kit where no illnesses or injuries have been reported. Per the rubric, recalls for risk-of-harm products without reported adverse events score High (3).
Plain-English summary
Bio-Rad Laboratories is recalling the QXDx BCR-ABL %IS Kit (REF: 12005660) due to incorrect calibrations and controls. The kit is used to measure BCR-ABL molecular response levels, which are important for monitoring certain leukemia patients.
Due to the calibration errors, the kit may produce lower or inaccurate International Scale (%IS) and molecular response values than the true patient values. This could result in incorrect test results that may affect patient treatment decisions.
The recall affects 33 units distributed nationwide to healthcare facilities in Pennsylvania, South Dakota, Texas, Florida, and Minnesota. Affected lot numbers are 64562656 and 64571846.
Patients whose results were generated using affected kits and healthcare providers should contact Bio-Rad Laboratories for information about obtaining corrected results or replacement testing.
The recalled product
- Product
- Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
- Manufacturer
- Bio-Rad Laboratories
- Hazard
- calibration-error
- inaccurate-test-results
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 64562656 & 64571846/ UDI: 03610521162834
Distribution
Distributed nationwide across the United States.
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