BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0387-2018 · Reported January 24, 2018

    Enforcement

    Recall Number
    Z-0387-2018
    Event ID
    78752
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Phadia US Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 24, 2018
    Initiation Date
    July 5, 2017
    Classification Date
    January 18, 2018
    Termination Date
    October 4, 2018
    Address
    4169 Commercial Ave, N/A, Portage, MI, 49002-9701, United States

    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.

    Code Info

    All versions of the instrument

    Distribution

    Nationwide

    Quantity

    70 units