BEUDAMED
    FDA Recall Terminated

    VIDAS 3 software v. 1.1.4

    Recall: Z-1200-2017 · Initiated January 11, 2017

    Recall

    Recall Number
    Z-1200-2017
    Event Number
    76281
    Firm
    BioMerieux SA Chemin De L'Orme Marcy L'Etoile France
    FEI Number
    1000611339
    Product Code
    LFZ
    Status
    Terminated
    Root Cause
    Software in the Use Environment
    Initiated
    January 11, 2017
    Posted
    February 14, 2017
    Terminated
    August 28, 2017

    Description

    VIDAS 3 software v. 1.1.4

    Reason

    During development of the VIDAS 3 software version 1.2, some anomalies have been identified and observed to be already present in the current software version VIDAS 3 version 1.1.4. available in the field.

    Action

    Consignees were notified via letter on January 11th, 2017.

    Distribution

    U.S.

    Quantity

    1161 units