Z-1358-2024 Class II Ongoing
FDA device recall Z-1358-2024 was initiated by Bio-Rad Laboratories on February 15, 2024 and is designated Class II. Reason for recall: Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values. The recall status is ongoing. Affected quantity: 33 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2024
- Initiation Date
- February 15, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33 units
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.
Distribution Pattern
US Nationwide distribution in the states of PA, SD, TX, FL, MN.
Code Information
Lot # 64562656 & 64571846/ UDI: 03610521162834