BEUDAMED
    FDA Recall Open, Classified

    The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.

    Recall: Z-1095-2026 · Initiated December 11, 2025

    Recall

    Recall Number
    Z-1095-2026
    Event Number
    98166
    Firm
    Instrumentation Laboratory
    FEI Number
    1217183
    Product Code
    GFO
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 11, 2025
    Posted
    January 15, 2026
    Address
    180 Hartwell Rd, Bedford, MA, 01730-2443

    Description

    The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.

    Reason

    Potential for microbial contamination.

    Action

    Werfen notified consignees on about 12/11/2025 via URGENT MEDICAL DEVICE RECALL letter. Consignees were instructed to check inventory for affected lots and destroy any on hand, document any destruction on the provided Urgent Mandatory Tracking Form, inform all laboratory personnel of the notification, forward the notification to all affected departments and locations within each facility, retain a copy of the notification for records, and complete and return the Mandatory Response Tracking Form provided.

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, FL, IL, MN, MS, NE, OH, TX, WI and the countries of Belgium, Netherlands, Luxembourg, Switzerland, China, Hong Kong, Israel, Italy, South Korea, Lithuania, Macao, Malaysia, Philippines, Qatar, Romania, Turkey, Kosovo.

    Quantity

    7,720 units