BEUDAMED
    FDA Recall Terminated

    Data reduction program written specifically for Bio-Tek ELx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit

    Recall: Z-0673-05 · Initiated April 12, 2004

    Recall

    Recall Number
    Z-0673-05
    Event Number
    30922
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    DBM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 12, 2004
    Posted
    April 6, 2005
    Terminated
    July 22, 2006
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    Data reduction program written specifically for Bio-Tek ELx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit

    Reason

    The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800 reader) was found to be faulty. This program is used to calculate the cut off values for Diastat Anti-Mitochondrial Antibody Kit. Program should include a borderline specification to indicate repeat testing is needed.

    Action

    A notification letter and effectiveness check form was sent to consignees. This letter recommended that users manually verify results using the specifications outlined in the package insert until a new software version is installed.

    Distribution

    CA, CT, KS, MA & WA

    Quantity

    8