BEUDAMED
    FDA Enforcement Class III Terminated

    TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkstation receives patient results from a connected instrument and sends them to a Laboratory Information System (LIS).

    Recall: Z-1310-2014 · Reported April 9, 2014

    Enforcement

    Recall Number
    Z-1310-2014
    Event ID
    67628
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Technidata S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 9, 2014
    Initiation Date
    February 17, 2014
    Classification Date
    March 31, 2014
    Termination Date
    March 31, 2014
    Address
    387, Avenue Jean Kuntzmannn, N/A, Montbonnot St Martin, N/A, N/A, France

    Description

    TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkstation receives patient results from a connected instrument and sends them to a Laboratory Information System (LIS).

    Reason

    If a conflict occurs between a Demography Query and a Result Transmission by the instrument, the TDWorkstation could send an incorrect patient demography to an instrument.

    Code Info

    version 11.01.A or higher

    Distribution

    Distributed in the state of PA.

    Quantity

    85 units total (1 unit in US)