BEUDAMED
    FDA Enforcement Class II Terminated

    MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.

    Recall: Z-1797-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1797-2018
    Event ID
    79621
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Diagnostic Hybrids, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 16, 2018
    Initiation Date
    July 14, 2016
    Classification Date
    May 10, 2018
    Termination Date
    August 28, 2020
    Address
    2005 E State St Ste 100, N/A, Athens, OH, 45701-2125, United States

    Description

    MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.

    Reason

    There is a possibility of low volume and/or leaking standard bottles.

    Code Info

    Lot 067850

    Distribution

    The products were distributed to the following US states: CA, CT, GA, IL, KY, MA, MD, MO, PA, TX, WA, and WI. The products were distributed to the following foreign countries: Australia, Brazil, Canada, China, Costa Rica, India, Japan, Mexico, The Philippines, Russia, South Korea, South Africa, Switzerland, and Uruguay.

    Quantity

    1004