BEUDAMED
    FDA Enforcement Class III Terminated

    MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.

    Recall: Z-1499-2018 · Reported May 2, 2018

    Enforcement

    Recall Number
    Z-1499-2018
    Event ID
    79642
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Diagnostic Hybrids, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 2, 2018
    Initiation Date
    November 3, 2015
    Classification Date
    April 24, 2018
    Termination Date
    August 28, 2020
    Address
    2005 E State St Ste 100, N/A, Athens, OH, 45701-2125, United States

    Description

    MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.

    Reason

    A component of the kit was found to contain bacterial contamination.

    Code Info

    Lot 052419

    Distribution

    Worldwide Distribution - USA (nationwide) to the states of : CO, CT, IA, IL, MN, MO, NC, NY, OH TX, and UT., and to the countries of : Switzerland, India, Hong Kong, and Japan.

    Quantity

    72 kits