Product: STA Liatest D-Di; REF: 00515;
This recall is currently active, issued October 16, 2025. It was issued by Diagnostica Stago, Inc..
- Company
- Diagnostica Stago, Inc.
- Recall Initiated
- September 12, 2025
- Posted
- October 16, 2025
- Recall Number
- Z-0205-2026
- Quantity
- 12740 units
- Firm Location
- Parsippany, NJ
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
REF: 00515; UDI-DI: 03607450005158; Lot numbers: 271382, 271411; Expiration 09/30/2025;
Root Cause
Under Investigation by firm
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.