BEUDAMED
    FDA Enforcement Class II Terminated

    Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017

    Recall: Z-2292-2019 · Reported August 28, 2019

    Enforcement

    Recall Number
    Z-2292-2019
    Event ID
    81420
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Luminex Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 28, 2019
    Initiation Date
    June 29, 2018
    Classification Date
    August 19, 2019
    Termination Date
    April 28, 2021
    Address
    12212 Technology Blvd, N/A, Austin, TX, 78727-6101, United States

    Description

    Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017

    Reason

    An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could result in sample/patient mismatch or duplicate results (from other patients specimens) for a patient order.

    Code Info

    ARIES System UDI: 00840487101537 ARIES M1 System UDI: 00840487100080 ARIES-M12V1-IVD, ARIES System ARIES-M6V1-IVD, ARIES M1 System CN-0321-01, ARIES System Handheld Barcode Scanner All scanners manufactured after April 2017 and including Part Number JDK-2330 Rev B.

    Distribution

    Worldwide distribution. US nationwide, Canada, Ireland, Netherlands, Singapore, Thailand, and United Kingdom

    Quantity

    153 (140 U.S. and 13 O.U.S.)