Tina-quant D-Dimer Test System — Class II medical device recall Z-0352-2024
Ongoing recall by Roche Diagnostics Operations, Inc., reported 2023-11-29, distributed nationwide. Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
| Recall number | Z-0352-2024 |
|---|---|
| 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 | 2023-10-03 |
| Classified | 2023-11-20 |
| Reported by FDA | 2023-11-29 |
| Distributed | Nationwide (US) |
| Quantity | 5,263 kits |
| UPC / GTIN / UDI-DI | 04015630914593, 07613336133651 |
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 for recall
Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
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-0352-2024. 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.