BEUDAMED
    FDA Enforcement Class II Ongoing

    V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.

    Recall: Z-2558-2019 · Reported October 2, 2019

    Enforcement

    Recall Number
    Z-2558-2019
    Event ID
    83607
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Vital Scientific N.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 2, 2019
    Initiation Date
    January 18, 2016
    Classification Date
    September 23, 2019
    Address
    24, Kanaalweg, Postbus 100, Dieren, N/A, Netherlands

    Description

    V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.

    Reason

    Instrument stopped working due to a software lockup, and no patient results are produced.

    Code Info

    Serial #s: 13-3341 and 13-3344

    Distribution

    US in the state of New York.

    Quantity

    2