BEUDAMED
    FDA Enforcement Class II Terminated

    TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034

    Recall: Z-1310-2022 · Reported July 6, 2022

    Enforcement

    Recall Number
    Z-1310-2022
    Event ID
    90323
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Haemonetics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    July 6, 2022
    Initiation Date
    April 26, 2022
    Classification Date
    June 30, 2022
    Termination Date
    March 15, 2024
    Address
    125 Summer St, Boston, MA, 02110-1616, United States

    Description

    TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034

    Reason

    Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference range, it could lead to misdiagnosis and incorrect treatment or failure to treat.

    Code Info

    UDI-DI: (01)20812747018095 All lots are affected.

    Distribution

    Domestic distribution US Nationwide.

    Quantity

    3933 kits (US); 2429 kits (OUS)