BEUDAMED
    FDA Recall 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 · Initiated May 22, 2017

    Recall

    Recall Number
    Z-2627-2017
    Event Number
    77426
    Firm
    Euro Diagnostica AB
    FEI Number
    3007610287
    Product Code
    LKJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 22, 2017
    Terminated
    March 31, 2021
    Address
    Box 50117, Lundavagen 151, Malmo 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.

    Action

    The firm initiated the problem by email on 05/22/2017. The consignee was directed to destroy the product.

    Distribution

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

    Quantity

    501 units