cobas HCYS — Class II medical device recall Z-0489-2025
Ongoing recall by Roche Diagnostics Operations, Inc., reported 2024-11-27, distributed in FL, IA, IN, NJ, NY, OK, SC, TX. Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produc
| Recall number | Z-0489-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2024-10-17 |
| Classified | 2024-11-19 |
| Reported by FDA | 2024-11-27 |
| Distributed | FL, IA, IN, NJ, NY, OK, SC, TX |
| Quantity | 458 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 04015630929979 |
| Lot numbers | 747029 |
| Model numbers | 06542921190 |
| Expiration dates | 2024-09-30 |
Product
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
Reason for recall
Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
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-0489-2025. 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.