BEUDAMED
    FDA Enforcement Class II Ongoing

    STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic, and immunologic assays.

    Recall: Z-2473-2025 · Reported September 3, 2025

    Enforcement

    Recall Number
    Z-2473-2025
    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 Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic, and immunologic assays.

    Reason

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

    Code Info

    Product Code: All references. UDI-DI: 03607450581041, 03607450581027. All software versions.

    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

    3,650 units (538 US)