BEUDAMED
    FDA Recall Terminated

    AUTION HYBRID AU-4050

    Recall: Z-1850-2019 · Initiated May 3, 2019

    Recall

    Recall Number
    Z-1850-2019
    Event Number
    82737
    Firm
    Arkray Factory USA, Inc.
    FEI Number
    1832816
    Product Code
    KQO
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 3, 2019
    Terminated
    September 17, 2020
    Address
    5182 W 76th St, Minneapolis, MN, 55439-2900

    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.

    Action

    The firm initiated the field correction by email on 05/03/2019. The letter stated how to recognize a product failure and the actions to be taking by the customer until the software upgrade is ready for installation.

    Distribution

    US

    Quantity

    159 units