Recall Z-0205-2026 · DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Diagnostica Stago, Inc.
Product: STA Liatest D-Di; REF: 00515;
| Date | Oct 16, 2025 (initiated Sep 12, 2025) |
| Status | Open, Classified |
| Reason | A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots. |
| Root cause | Under Investigation by firm |
| Action | On September 12, 2025 URGENT: MEDICAL DEVICE RECALL (REMOVAL) letters were emailed to customers. Actions for customers: Discontinue use of affected lots and dispose of them in accordance with your local regulations. Complete and return response form. For additional information, please contact Stago's 24/7 Hotline at 1-800-725-0607. |
| Quantity | 12740 units |
| Distribution | Worldwide distribution- US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |