BEUDAMED
    FDA Recall Terminated

    PolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent Titration System, DiaSorin part # PT100 which is programmed for DiaSorin ANAFLUOR Indirect fluroescent Antibody Test For the detection and titration of circulating antinuclear antibodies. REF: 1624, 1662, 1660, 6624, 1604

    Recall: Z-0676-05 · Initiated June 30, 2004

    Recall

    Recall Number
    Z-0676-05
    Event Number
    30934
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    DHN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 30, 2004
    Posted
    April 6, 2005
    Terminated
    July 22, 2006
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    PolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent Titration System, DiaSorin part # PT100 which is programmed for DiaSorin ANAFLUOR Indirect fluroescent Antibody Test For the detection and titration of circulating antinuclear antibodies. REF: 1624, 1662, 1660, 6624, 1604

    Reason

    The program for a specific immunofluorescent titration system (Polymedco PolyTiter immunofluorescent Titration System) was found faulty in that the calibrator 2 value was incorrectly programmed as 1:120 instead of 1:160.

    Action

    All customers were notified of the problem via phone and letter. Verbal instructions were given of how to change the Calibrator 2 titer to the correct one. A letter instructs customer to return software disc to DiaSorin, remove version 2.8 from the computer and install version 2.8.1.

    Distribution

    AL, AZ, CA, CO, FL, KY, MO, NC, NJ, NV, OH, TX, & VA

    Quantity

    14