BEUDAMED
    FDA Enforcement Class II Terminated

    ARIES System and ARIES M1 System

    Recall: Z-2094-2017 · Reported May 24, 2017

    Enforcement

    Recall Number
    Z-2094-2017
    Event ID
    77052
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Luminex Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 24, 2017
    Initiation Date
    April 19, 2017
    Classification Date
    May 16, 2017
    Termination Date
    October 20, 2017
    Address
    12212 Technology Blvd, Austin, TX, 78727-6101, United States

    Description

    ARIES System and ARIES M1 System

    Reason

    The hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen identifications on the ARIES Systems populates patient sample IDs with a previously scanned sample ID when entering orders into an ARIES instrument.

    Code Info

    ARIES System UDI: 00840487101537 and ARIES M1 System UDI: 00840487100080

    Distribution

    Worldwide Distribution - US Distribution and to the countries of Finland and China.

    Quantity

    15 units