BEUDAMED
    FDA Recall Terminated

    AIA-360 Automated Immunoassay Analyzer, Product Code 019945

    Recall: Z-1420-2020 · Initiated January 10, 2020

    Recall

    Recall Number
    Z-1420-2020
    Event Number
    84787
    Firm
    Tosoh Bioscience Inc
    FEI Number
    3005529799
    Product Code
    KHO
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 10, 2020
    Posted
    February 11, 2020
    Terminated
    September 10, 2020
    Address
    3600 Gantz Rd, Grove City, OH, 43123-1895

    Description

    AIA-360 Automated Immunoassay Analyzer, Product Code 019945

    Reason

    A display screen software issue on the analyzer causes the display to freeze when display screen is touched at the same time as a command from the instrument firmware, causing the instrument to stop. As a result, the run is aborted and the results are not retrievable.

    Action

    The firm distributed Urgent Medical Device Correction letters to customers on January 10, 2020. Customers were instructed to retrain from touching the display panel while the analyzer is running. If the analyzer stops and/or the display freezes, please contact Tosoh Technical Support 24 hours a day, seven days a week at (800) 248-6764. If your analyzer's serial number is listed among the recalled units, you will be contacted by a Tosoh Field Service Engineer to schedule a visit to replace the display screen which will correct the potential issue. Should you have any questions regarding this medical device recall, please feel free to contact Bernadette OConnell at (800) 248-6764 or by email at [email protected]. She will be available to answer any questions Monday - Friday, from 9:00 AM to 5:00 PM (PST).

    Distribution

    Distributed to AZ, NE, NJ, NY, and WA. Foreign distribution to Cayman Islands, Costa Rica, and Uruguay

    Quantity

    12