BEUDAMED
    FDA Recall Open, Classified

    Product: STA Liatest D-Di; REF: 00515;

    Recall: Z-0205-2026 · Initiated September 12, 2025

    Recall

    Recall Number
    Z-0205-2026
    Event Number
    97596
    Firm
    Diagnostica Stago, Inc.
    FEI Number
    2245451
    Product Code
    DAP
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    September 12, 2025
    Posted
    October 16, 2025
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607

    Description

    Product: STA Liatest D-Di; REF: 00515;

    Reason

    A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.

    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.

    Distribution

    Worldwide distribution- US Nationwide and the country of Canada.

    Quantity

    12740 units