Product: STA Liatest D-Di; REF: 00515;
FDA device recall Z-0205-2026 · posted 2025-10-16 · Open, Classified
Recall details
- Recalling firm
- Diagnostica Stago, Inc.
- Reason for recall
- A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- DAP
- Quantity affected
- 12740 units
- Distribution
- Worldwide distribution- US Nationwide and the country of Canada.
- Date initiated
- 2025-09-12
- Date posted
- 2025-10-16
- Location
- Parsippany, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STA® - Liatest® D-Di (K162227) | Diagnostica Stago | 2016-12-10 |
| STA LIATEST D-DI (K141144) | Diagnostica Stago | 2014-09-03 |
| STA-LIATEST D-DI TEST KIT (K964728) | American Bioproducts Co. | 1997-06-26 |