BEUDAMED
    FDA Recall Terminated

    Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin ANAFLUOR Indirect Fluorescent Antibody Test.

    Recall: Z-0807-05 · Initiated September 24, 2004

    Recall

    Recall Number
    Z-0807-05
    Event Number
    30946
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    DHN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 24, 2004
    Posted
    May 10, 2005
    Terminated
    July 22, 2006
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin ANAFLUOR Indirect Fluorescent Antibody Test.

    Reason

    A problem with software for the PolyTiter Immunofluorescent Titration System in that no flags or warnings appear when PolyTiter Calibrator Values are re-entered or changed (including values changed to unacceptable values) after the initial curve has been generated, if the 'refresh button' has not been pressed. The graph may appear valid; however erroneous results may occur.

    Action

    Customers were sent a Technical Bulletin describing the correct procedure to be used when entering data into the Poly/Titer tiration system, until the updated software is installed

    Distribution

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

    Quantity

    13