Product: STA Liatest D-Di — Class II medical device recall Z-0205-2026
Ongoing recall by Diagnostica Stago, Inc., reported 2025-10-22, distributed nationwide. A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
| Recall number | Z-0205-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diagnostica Stago, Inc., Parsippany, NJ, United States |
| Recall initiated | 2025-09-12 |
| Classified | 2025-10-16 |
| Reported by FDA | 2025-10-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 12,740 units |
| UPC / GTIN / UDI-DI | 03607450005158 |
| Lot numbers | 271382, 271411 |
| Model numbers | 00515 |
| Expiration dates | 2025-09-30 |
Product
Product: STA Liatest D-Di; REF: 00515;
Reason for recall
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
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-0205-2026. 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.