BEUDAMED
    FDA Enforcement Class III Terminated

    DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA, histone and centromere antigens.

    Recall: Z-2627-2017 · Reported July 5, 2017

    Enforcement

    Recall Number
    Z-2627-2017
    Event ID
    77426
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Euro Diagnostica AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 5, 2017
    Initiation Date
    May 22, 2017
    Classification Date
    June 23, 2017
    Termination Date
    March 31, 2021
    Address
    Box 50117, Lundavagen 151, Malmo, N/A, N/A, Sweden

    Description

    DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA, histone and centromere antigens.

    Reason

    FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit box of the lot informed customers that the shelf-life had been shortened and referenced a letter sent to customers for more information, where the new expiration date was stated. The original kit box label remained on the kit box stating the original expiration date, the packaging did not display the correct expiration date.

    Code Info

    TS 3577

    Distribution

    MN, TX, NE, PA, Spain, Egypt, Pakistan, Nepal, Canada

    Quantity

    501 units