BEUDAMED
    FDA Recall Terminated

    Phadia 1000 Instrument, Article Number 12-3800-01.

    Recall: Z-0387-2018 · Initiated July 5, 2017

    Recall

    Recall Number
    Z-0387-2018
    Event Number
    78752
    Firm
    Phadia US Inc
    FEI Number
    3004973408
    Product Code
    DHB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 5, 2017
    Terminated
    October 4, 2018
    Address
    4169 Commercial Ave, Portage, MI, 49002-9701

    Description

    Phadia 1000 Instrument, Article Number 12-3800-01.

    Reason

    The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.

    Action

    The firm sent letters with a return response form to customers. The firm instructed customers to immediately choose the "stop" command if presented with the 7-101 Liquid Sensor Error. Results from the assay should not be approved. A revision of the current software will have a mandatory installation soon.

    Distribution

    Nationwide

    Quantity

    70 units