Device product
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Z-1358-2024
Product summary
- Event
- Event 94020
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 33 units
- Official record key
device-enforcement:Z-1358-2024
Official wording
Reason: Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
Code information: Lot # 64562656 & 64571846/ UDI: 03610521162834
Distribution pattern: US Nationwide distribution in the states of PA, SD, TX, FL, MN.
Derived failure modes
-
Unknown
Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.