FDA recall Z-0205-2026
Diagnostica Stago, Inc. · Class II · device
Product
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
Worldwide distribution- US Nationwide and the country of Canada.
Key facts
- Status
- Ongoing
- Initiation date
- 2025-09-12
- Report date
- 2025-10-22
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Parsippany, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0205-2026