FDA Device recall Z-0352-2024
Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502
- FDA Device
- Class II
- ongoing
- Published 2023-11-29
On 2023-11-29 the FDA classified a Class II recall of Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502 by Roche Diagnostics Operations, citing elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0352-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-03 |
| Published | 2023-11-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
Product
Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503)
Reason
Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
Identifiers
| code_info | All Lots Affected. UDI: 04015630914593 - (cobas c 311, 501 and 502; INTEGRA 400 plus) UDI: 07613336133651 - (cobas c 303 and 503) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0352-2024%22
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