Bio-Rad Laboratories Recall 94020
Description: Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Bio-Rad Laboratories Recall 94020 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1358-2024 |
| Event ID | 94020 |
| Event Description | Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of PA, SD, TX, FL, MN. |
| Quantity | 33 units |
| Recall Reason | Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values. |
| Device Classification | 20240403 |
| Device Code Info | Lot # 64562656 & 64571846/ UDI: 03610521162834 |
| Center Classification Date | 20240322 |
| Recall Initiation Date | 20240215 |
| Recalling Firm | Bio-Rad Laboratories |
| Initial Notification | |
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