BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated July 21, 2025

    Recall

    Recall Number
    Z-2476-2025
    Event Number
    97287
    Firm
    Diagnostica Stago, Inc.
    FEI Number
    2245451
    Product Code
    KQJ
    Status
    Open, Classified
    Root Cause
    Mixed-up of materials/components
    Initiated
    July 21, 2025
    Posted
    August 28, 2025
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607

    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.

    Action

    Diagnostica Stago notified consignees on about 07/21/2025 via emailed letter titled URGENT: MEDICAL DEVICE RECALL (CORRECTION). Consignees were instructed to temporarily systematically run a quality control just before a batch of UFH or LMWH, if you run STA-LIQUID ANTI-Xa in UFH and LMWH applications on your STA SATELLITE analyzer. This request is being asked while Stago works to develop a permanent solution for the analyzer. Consignees were also requested to complete and return the Acknowledgement Form and to notify customers if affected units were transferred or further distributed.

    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)