Z-0205-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 22, 2025
- Initiation Date
- September 12, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12740 units
Product Description
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.
Distribution Pattern
Worldwide distribution- US Nationwide and the country of Canada.
Code Information
REF: 00515; UDI-DI: 03607450005158; Lot numbers: 271382, 271411; Expiration 09/30/2025;