Bio-Rad — Class II medical device recall Z-1358-2024
Ongoing recall by Bio-Rad Laboratories, reported 2024-04-03, distributed nationwide. Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molec
| Recall number | Z-1358-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bio-Rad Laboratories, Pleasanton, CA, United States |
| Recall initiated | 2024-02-15 |
| Classified | 2024-03-22 |
| Reported by FDA | 2024-04-03 |
| Distributed | Nationwide (US) |
| Quantity | 33 units |
| UPC / GTIN / UDI-DI | 03610521162834 |
| Lot numbers | 64562656, 64571846 |
| Model numbers | 12005660 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1358-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.