Device product
Product: STA Liatest D-Di; REF: 00515;
Z-0205-2026
Product summary
- Event
- Event 97596
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12740 units
- Official record key
device-enforcement:Z-0205-2026
Official wording
Reason: A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
Code information: REF: 00515; UDI-DI: 03607450005158; Lot numbers: 271382, 271411; Expiration 09/30/2025;
Distribution pattern: Worldwide distribution- US Nationwide and the country of Canada.
Derived failure modes
-
Unknown
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.