Class II — Diagnostica Stago, Inc.
| Recalling firm | Diagnostica Stago, Inc. |
|---|---|
| Registered facility | DIAGNOSTICA STAGO, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots. |
| Product | Product: STA Liatest D-Di; REF: 00515; |
| Quantity | 12740 units |
| Distribution | Worldwide distribution- US Nationwide and the country of Canada. |
| Initiated | 2025-09-12 |
| Classified | 2025-10-16 |
| Recall number | Z-0205-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Diagnostica Stago, Inc. (Z-0205-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97596/
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