BEUDAMED
    FDA Recall Terminated

    is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sjgren's syndrome and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.

    Recall: Z-2919-2018 · Initiated October 21, 2016

    Recall

    Recall Number
    Z-2919-2018
    Event Number
    80684
    Firm
    Euro Diagnostica AB
    FEI Number
    3007610287
    Product Code
    LKO
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    October 21, 2016
    Posted
    August 23, 2018
    Terminated
    November 5, 2019
    Address
    Box 50117, Lundavagen 151, Malmo Sweden

    Description

    is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sjgren's syndrome 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.

    Action

    none

    Distribution

    MN

    Quantity

    4