FDA Device recall Z-0205-2026
Product: STA Liatest D-Di
- FDA Device
- Class II
- ongoing
- Published 2025-10-22
On 2025-10-22 the FDA classified a Class II recall of Product: STA Liatest D-Di by Diagnostica Stago, citing A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0205-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-12 |
| Published | 2025-10-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Diagnostica Stago |
| Distribution | US |
Product
Product: STA Liatest D-Di; REF: 00515;
Reason
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
Identifiers
| code_info | REF: 00515; UDI-DI: 03607450005158; Lot numbers: 271382, 271411; Expiration 09/30/2025; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0205-2026%22
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