Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Reported: April 3, 2024 Initiated: February 15, 2024 #Z-1358-2024
Product Description
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Reason for Recall
Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
Details
- Recalling Firm
- Bio-Rad Laboratories
- Units Affected
- 33 units
- Distribution
- US Nationwide distribution in the states of PA, SD, TX, FL, MN.
- Location
- Pleasanton, CA
Frequently Asked Questions
What product was recalled? ▼
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit. Recalled by Bio-Rad Laboratories. Units affected: 33 units.
Why was this product recalled? ▼
Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 3, 2024. Severity: Moderate. Recall number: Z-1358-2024.
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