BEUDAMED
    FDA Enforcement Class II Ongoing

    Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.

    Recall: Z-1503-2025 · Reported April 9, 2025

    Enforcement

    Recall Number
    Z-1503-2025
    Event ID
    96488
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fisher Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 9, 2025
    Initiation Date
    March 6, 2025
    Classification Date
    March 31, 2025
    Address
    8365 Valley Pike, Middletown, VA, 22645-1905, United States

    Description

    Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.

    Reason

    The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.

    Code Info

    Catalog No. 100357; UDI: 00845275000798665150270131100357; Lot No. 665150; Exp. Date 01/31/2027.

    Distribution

    US Distribution to: PA and OUS Foreign country of: United Arab Emirates.

    Quantity

    1,699 units