STA Liatest D-Di (Diagnostica Stago) – D-Dimer Level Underestimation (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Product: STA Liatest D-Di; REF: 00515;
Brand
Diagnostica Stago, Inc.
Lot Codes / Batch Numbers
REF: 00515, UDI-DI: 03607450005158, Lot numbers: 271382, 271411, Expiration 09/30/2025
Products Sold
REF: 00515; UDI-DI: 03607450005158; Lot numbers: 271382, 271411; Expiration 09/30/2025;
Diagnostica Stago, Inc. is recalling Product: STA Liatest D-Di; REF: 00515; due to A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026