BEUDAMED
    FDA Enforcement Class II Terminated

    AIA-900 Analyzer, Product code 022930, 022930R

    Recall: Z-0469-2019 · Reported November 21, 2018

    Enforcement

    Recall Number
    Z-0469-2019
    Event ID
    81187
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tosoh Bioscience Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 21, 2018
    Initiation Date
    October 5, 2018
    Classification Date
    November 14, 2018
    Termination Date
    November 10, 2020
    Address
    3600 Gantz Rd, Grove City, OH, 43123-1895, United States

    Description

    AIA-900 Analyzer, Product code 022930, 022930R

    Reason

    Tosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor on the AIA-900 Analyzer. If the pickup arm or pickup arm motor malfunctions, the analyzer will cease to function and result in an inability to test patient samples. This may cause a delay in testing and reporting patient results. Tosoh has received fifty-one (51) complaints related to this issue with no serious injuries reported.

    Code Info

    All units are affected

    Distribution

    Distributed nationwide. Foreign distribution to Canada and Latin America.

    Quantity

    393