Recall Z-1358-2024 ยท OYX Bcr/Abl1 Monitoring Test
Bio-Rad Laboratories
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
| Date | Mar 22, 2024 (initiated Feb 15, 2024) |
| Status | Open, Classified |
| Reason | Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values. |
| Root cause | Nonconforming Material/Component |
| Action | On February 7, 2024, Bio-Rad issued their initial "Urgent Medical Device Correction" notification via E-Mail. On February 14, 2023, Bio RAD Laboratories issued a revised "Urgent Medical Device Correction" notification via E-Mail. Bio-Rad asked consignees to take the following actions: 1. Confirm past patient results against correct values for Catalog No. 12005560, Batch Nos. 64562656 and 64571846 when provided with corrected calibrator values by Bio-Rad Laboratories. 2. If all the controls values fall within the corrected ranges, no further action is required. If one or more controls are o |
| Quantity | 33 units |
| Distribution | US Nationwide distribution in the states of PA, SD, TX, FL, MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System Bio-Rad Laboratories, Inc., Feb 13, 2019 |