BEUDAMED
    FDA Enforcement Class II Ongoing

    STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determination of fibrinogen levels in human citrated plasma by the clotting method of Clauss.

    Recall: Z-2476-2025 · Reported September 3, 2025

    Enforcement

    Recall Number
    Z-2476-2025
    Event ID
    97287
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Diagnostica Stago, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 3, 2025
    Initiation Date
    July 21, 2025
    Classification Date
    August 29, 2025
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607, United States

    Description

    STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determination of fibrinogen levels in human citrated plasma by the clotting method of Clauss.

    Reason

    Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

    Code Info

    Model/Catalog Number: 00674. UDI-DI: 13607450006749

    Distribution

    Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, LA, MD, ME, MN, MO, MT, NC, OH, OK, OR, PA, PR, SD, VT, WI, WY and the countries of Algeria, Argentina, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, France, French Polynesie, Guadeloupe, India, Iran, Israel, Jordan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Oman, Paraguay, Peru, Republique Tcheque, Romania, Saudi Arabia, Serbia, South Africa, Switzerland, Taiwan, Thailand, Tunisia, Turquie, United Arab Emirates, Uruguay, Vietnam.

    Quantity

    829,800 units (245,200 US)