BEUDAMED
    FDA Enforcement Class II Terminated

    Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.

    Recall: Z-0158-2020 · Reported October 23, 2019

    Enforcement

    Recall Number
    Z-0158-2020
    Event ID
    83582
    Classification
    Class II
    Status
    Terminated
    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 23, 2019
    Initiation Date
    January 10, 2012
    Classification Date
    October 16, 2019
    Termination Date
    April 19, 2024
    Address
    24, Kanaalweg, Postbus 100, Dieren, N/A, N/A, Netherlands

    Description

    Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.

    Reason

    The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

    Code Info

    serial numbers: 11-9609; 11-9690; 11-9694; 11-9695; 12-9618; 12-9620.

    Distribution

    US Nationwide in the states of NY, and UT

    Quantity

    6 instruments