BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0205-2026 · Reported October 22, 2025

    Enforcement

    Recall Number
    Z-0205-2026
    Event ID
    97596
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Diagnostica Stago, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 22, 2025
    Initiation Date
    September 12, 2025
    Classification Date
    October 16, 2025
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607, United States

    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.

    Code Info

    REF: 00515; UDI-DI: 03607450005158; Lot numbers: 271382, 271411; Expiration 09/30/2025;

    Distribution

    Worldwide distribution- US Nationwide and the country of Canada.

    Quantity

    12740 units