Diagnostica Stago, Inc.: Device Recall
Recall #Z-0205-2026 · 09/12/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0205-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Diagnostica Stago, Inc.
- Status
- Ongoing
- Date Initiated
- 09/12/2025
- Location
- Parsippany, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12740 units
Reason for Recall
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
Product Description
Product: STA Liatest D-Di; REF: 00515;
Distribution Pattern
Worldwide distribution- US Nationwide and the country of Canada.
Other Recalls by Diagnostica Stago, Inc.
- Class II: Risk 12/15/2025
- Class II: Risk 07/21/2025
- Class II: Risk 07/21/2025
- Class II: Risk 07/21/2025
- Class II: Risk 07/21/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.