FDA Device recall Z-1358-2024
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
- FDA Device
- Class II
- ongoing
- Published 2024-04-03
On 2024-04-03 the FDA classified a Class II recall of Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit by Bio Rad Laboratories, citing due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1358-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-15 |
| Published | 2024-04-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Bio Rad Laboratories |
| Distribution | US |
Product
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Reason
Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
Identifiers
| code_info | Lot # 64562656 & 64571846/ UDI: 03610521162834 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1358-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.