BEUDAMED
    FDA Enforcement Class II Terminated

    AUTION HYBRID AU-4050

    Recall: Z-1850-2019 · Reported June 26, 2019

    Enforcement

    Recall Number
    Z-1850-2019
    Event ID
    82737
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arkray Factory USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 26, 2019
    Initiation Date
    May 3, 2019
    Classification Date
    June 20, 2019
    Termination Date
    September 17, 2020
    Address
    5182 W 76th St, N/A, Minneapolis, MN, 55439-2900, United States

    Description

    AUTION HYBRID AU-4050

    Reason

    This correction is being initiated due to a software issue which results in the possibility of incorrect patient information being assigned to sample results when the following rare combination of three specific events were to occur: 1) No measurement results are generated due to an error by a urine sediment measurement. 2) The instrument is shutdown incorrectly. 3) An item rack is used for subsequent sample measurements.

    Code Info

    UDI: (01) 00015482146030 All serial numbers

    Distribution

    US

    Quantity

    159 units