BEUDAMED
    FDA Enforcement Class II Terminated

    Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results.

    Recall: Z-2397-2019 · Reported September 4, 2019

    Enforcement

    Recall Number
    Z-2397-2019
    Event ID
    83402
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Phadia Ab
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2019
    Initiation Date
    July 9, 2019
    Classification Date
    August 26, 2019
    Termination Date
    July 12, 2022
    Address
    Rapsgatan Plant, Rapsgatan 7, Uppsala, N/A, N/A, Sweden

    Description

    Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results.

    Reason

    code 7-102 Liquid Sensor Error

    Code Info

    All Serial Numbers; Unique Device Identifier (UDI): 07333066001005

    Distribution

    US Nationwide Distribution in the states of CA CO FL GA HI IL IN KS KY MA MD MI MO NC NJ NV NY OH OK OR PA TN TX UT VA WA

    Quantity

    387 Instruments