FDA Device recall Z-0489-2025
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocystei…
- FDA Device
- Class II
- ongoing
- Published 2024-11-27
On 2024-11-27 the FDA classified a Class II recall of cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocystei… by Roche Diagnostics Operations, citing abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0489-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-17 |
| Published | 2024-11-27 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | FL, IA, IN, NJ, NY, OK, SC, TX |
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
Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
Identifiers
| code_info | UDI/DI 04015630929979, Lot Number 747029, exp. 30-SEPT-2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0489-2025%22
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