BEUDAMED
    FDA Recall Terminated

    TD-Synergy. Laboratory Information System.

    Recall: Z-1345-2013 · Initiated July 29, 2010

    Recall

    Recall Number
    Z-1345-2013
    Event Number
    56447
    Firm
    Technidata S.A. 387, Avenue Jean Kuntzmannn Montbonnot St Martin France
    FEI Number
    3003995437
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 29, 2010
    Posted
    May 21, 2013
    Terminated
    December 5, 2013

    Description

    TD-Synergy. Laboratory Information System.

    Reason

    Technidata has discovered that using the F8 key in the ERM session to add a combined test can result in the modification of the value of a result that has already been entered for a test of the request.

    Action

    The firm, Technidata, sent an "P1 DEFECT INFORMATION" notice dated July 2, 2010 to their consignee/customers. The notice describes the product, problem and actions to be taken. The notice directs them to find the correction to the software issue on the Technidata website where they are able to install the correction kit depending on the version and operating system used. Note "You must back up the database and the installation directory before installing this correction". Should you need any further information, do not hesitate to contact the Support team at +33 (0) 4 76 04 13 00.

    Distribution

    Worldwide Distribution-USA (nationwide) including Washington DC and the states of California, Nevada, Kentucky, Alabama, Rhode Island, Pennsylvania, and Louisiana and the country of Italy.

    Quantity

    10