BEUDAMED
    FDA Enforcement Class II Terminated

    Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic process.

    Recall: Z-0306-2018 · Reported January 10, 2018

    Enforcement

    Recall Number
    Z-0306-2018
    Event ID
    77107
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Euro Diagnostica AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 10, 2018
    Initiation Date
    February 14, 2017
    Classification Date
    December 29, 2017
    Termination Date
    May 16, 2018
    Address
    Box 50117, Lundavagen 151, Malmo, N/A, N/A, Sweden

    Description

    Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic process.

    Reason

    Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS 2076. The kit might not perform correctly and so potentially yield false positive samples.

    Code Info

    Lot: TS 2076

    Distribution

    MN, NE, TX

    Quantity

    534 kits