BEUDAMED
    FDA Enforcement Class III Terminated

    is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.

    Recall: Z-2922-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2922-2018
    Event ID
    80684
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Euro Diagnostica AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 29, 2018
    Initiation Date
    October 21, 2016
    Classification Date
    August 23, 2018
    Termination Date
    November 5, 2019
    Address
    Box 50117, Lundavagen 151, Malmo, N/A, Sweden

    Description

    is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.

    Reason

    Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.

    Code Info

    Lot #'s: TS 1740 (kit) and TS 1743 (PC)

    Distribution

    MN

    Quantity

    4