BEUDAMED
    FDA Enforcement Class II Terminated

    MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.

    Recall: Z-0417-2015 · Reported September 9, 2015

    Enforcement

    Recall Number
    Z-0417-2015
    Event ID
    69545
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Diagnostic Hybrids Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 9, 2015
    Initiation Date
    October 16, 2014
    Classification Date
    September 3, 2015
    Termination Date
    September 3, 2015
    Address
    1055 E State St, Suite 100, Athens, OH, 45701-7911, United States

    Description

    MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.

    Reason

    Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.

    Code Info

    Model Number A027; Lot Number 018186; (self-affixed, EDMA Code: 12 01 02 04 00; Complement Component Bb)

    Distribution

    Worldwide Distribution - USA, including AL, CO, CT, FL, KY, MN, NC, NV, OH, PA, and WA; and, the countries of Canada, China, India, and Switzerland.

    Quantity

    171