Product: STA Liatest D-Di; REF: 00515;
FDA Recall #Z-0205-2026 — Class II — September 12, 2025
Product Description
Product: STA Liatest D-Di; REF: 00515;
Reason for Recall
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
Recalling Firm
Diagnostica Stago, Inc. — Parsippany, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
12740 units
Distribution
Worldwide distribution- US Nationwide and the country of Canada.
Code Information
REF: 00515; UDI-DI: 03607450005158; Lot numbers: 271382, 271411; Expiration 09/30/2025;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated