BEUDAMED
    FDA Enforcement Class II Terminated

    TD-Synergy. Laboratory Information System.

    Recall: Z-1345-2013 · Reported May 29, 2013

    Enforcement

    Recall Number
    Z-1345-2013
    Event ID
    56447
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Technidata S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 29, 2013
    Initiation Date
    July 29, 2010
    Classification Date
    May 21, 2013
    Termination Date
    December 5, 2013
    Address
    387, Avenue Jean Kuntzmannn, N/A, Montbonnot St Martin, N/A, N/A, France

    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.

    Code Info

    TD Lims product versions: LIS (ALLX)-21.041-_ML-5370, LIS (ALLX)-22.021-_ML-5374, TD-Synergy product versions: SYN (ALLX)- 03.13B-_ML-5368, SYN (ALLX)- 03.141-_ML-5369, SYN(LINUX)-06.011-_ML-5381, SYN (ALLX)-11.11B-_ML-5345, SYN (ALLX)-11.21B-_ML-5346 SYN (ALL)- 11.31C-_ML-5372, SYN (LINUX)-11.321-_FR-5382, SYN (ALL)-11.321-_ML-5373

    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