BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1503-2025 · Initiated March 6, 2025

    Recall

    Recall Number
    Z-1503-2025
    Event Number
    96488
    Firm
    Fisher Diagnostics
    FEI Number
    1181121
    Product Code
    GJS
    Status
    Open, Classified
    Root Cause
    Employee error
    Initiated
    March 6, 2025
    Posted
    March 31, 2025
    Address
    8365 Valley Pike, Middletown, VA, 22645-1905

    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.

    Action

    A "Recall/Field Safety Corrective Action" letter dated 3/5/25 was mailed to consignees instructing them to stop using and discard any affected product in stock, contact their prescribing physicians/Medical Directors for evaluation for further action, and retain a copy of the notification for laboratory records. Consignees are to return the provided Response Form. Consignees with any questions are to contact their Fisher Diagnostic representative or call 800-528-0494. Distributors are to email [email protected] with "CDR-FSN-2025-001" in the subject line to coordinate replacements.

    Distribution

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

    Quantity

    1,699 units