BEUDAMED
    FDA Enforcement Class III Terminated

    TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S)

    Recall: Z-1743-2013 · Reported July 24, 2013

    Enforcement

    Recall Number
    Z-1743-2013
    Event ID
    65652
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Technidata S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 24, 2013
    Initiation Date
    June 20, 2013
    Classification Date
    July 17, 2013
    Termination Date
    July 29, 2013
    Address
    387, Avenue Jean Kuntzmannn, N/A, Montbonnot St Martin, N/A, N/A, France

    Description

    TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S)

    Reason

    A recall was initiated by Technidata because use of symbols (less than or equal to or greater than or equal to or any other symbol) in Microsoft Word reports when using electronic transmissions of results by of HPRIM (including HPRIM Medecin via Kermit) or HL7 must be absolutely prohibited. Such symbols are not supported by the Microsoft Word interface used by the Histology/Cytology software and

    Code Info

    All TDHistology/Cytology product versions.

    Distribution

    US Distribution CA only.

    Quantity

    1 site