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.
Other recalls by Roche Diagnostics Operations
- cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU,…
FDA Device · Class II · 2026-03-11 · Roche Diagnostics Operations - The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminesce…
FDA Device · Class II · 2026-01-14 · Roche Diagnostics Operations - 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 · 2024-11-27 · Roche Diagnostics Operations - Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine ki…
FDA Device · Class II · 2024-10-02 · Roche Diagnostics Operations - cobas infinity central lab, Material Number 07154003001
FDA Device · Class II · 2023-01-18 · Roche Diagnostics Operations
All Roche Diagnostics Operations recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0352-2024%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.