BEUDAMED
    FDA Recall Terminated

    Version 12 software program written for the Bio-Tek ELx800 automated microtiter plate reader with use of PRO-Trac Tacrolimus ELISA kit

    Recall: Z-0702-05 · Initiated April 12, 2004

    Recall

    Recall Number
    Z-0702-05
    Event Number
    30929
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    MLM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 12, 2004
    Posted
    April 13, 2005
    Terminated
    July 22, 2006
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    Version 12 software program written for the Bio-Tek ELx800 automated microtiter plate reader with use of PRO-Trac Tacrolimus ELISA kit

    Reason

    The software program written for use in the automated microtiter plate reader (Bio-Tek ELx800) for use with the Pro-Trac II Tacrolimus ELISA kit was found to be faulty. Assay software program did not include the Calibrator Zero OD specification (STDO>=1.500) as specified in the product insert.

    Action

    Customers were sent notification letters and effectiveness check form. recommended users manually veify results using product insert specifications.

    Distribution

    CA, Washington DC, FL, KY & Canada