BEUDAMED
    FDA Recall Terminated

    Data reduction program software written specifically for Bio-Tek ELx800 (DiaSorin part # 15713) automated microtiter plate reader with use of Diastat Anti-Thyroglobulin Assay (manufacturer part #7700).

    Recall: Z-0675-05 · Initiated April 12, 2004

    Recall

    Recall Number
    Z-0675-05
    Event Number
    30928
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    JZO
    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 software written specifically for Bio-Tek ELx800 (DiaSorin part # 15713) automated microtiter plate reader with use of Diastat Anti-Thyroglobulin Assay (manufacturer part #7700).

    Reason

    The data reduction program written for a specific automated microtiter plate reader (Bio-Tek ELx800) was found to be faulty. This program is used to calculate the cut off values for the Diastat Anti-Thyroglobulin Kit assay. The negative Control Upper Limit should be less than 0.95, rather than less than 1.0.

    Action

    Customers were sent a notification letter directing customers to check historical data for negative control results reading greater than 0.95 but less than 1.0. These results are invalid and patient results should not have been reported. Customers are instructed to verify negative control manually until new software version is installed. An effectiveness check form is requested to be returned.

    Distribution

    CA, FL, MA, NY & TX

    Quantity

    6