FDAHealthSeptember 12, 2025
Diagnostica Stago, Inc. — Product: STA Liatest D-Di; REF: 00515;
⚠️ A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 12, 2025
Worldwide distribution- US Nationwide and the country of Canada.
What's affected?
- Product
- Product: STA Liatest D-Di; REF: 00515;
- Lot code
- 271382
Additional details
REF: 00515; UDI-DI: 03607450005158; Lot numbers: 271382, 271411; Expiration 09/30/2025;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 12740 units.
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