BEUDAMED
    FDA Recall Terminated

    Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800) reader) for use with Diastat Anti-Beta2 Glycoprotein ELISA assay kit.

    Recall: Z-0674-05 · Initiated October 26, 2004

    Recall

    Recall Number
    Z-0674-05
    Event Number
    30924
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    MSV
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 26, 2004
    Posted
    April 6, 2005
    Terminated
    July 22, 2006
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800) reader) for use with Diastat Anti-Beta2 Glycoprotein ELISA assay kit.

    Reason

    Data reduction Program written for specific sutomated microtiter plate insturment (Bio-Tek ELx800 reader) is faulty in that the positive result limit is to be greater than 15 U/ml, rather than greater than or equal to 15 U/ml.

    Action

    Customers were sent notification letters and effectiveness check form. recommended users manually veify positve results (RSLT), using product insert specifications.

    Distribution

    CT, MI, MT, UT & CANADA

    Quantity

    7