BEUDAMED
    FDA Recall Terminated

    MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.

    Recall: Z-1498-2018 · Initiated November 3, 2015

    Recall

    Recall Number
    Z-1498-2018
    Event Number
    79642
    Firm
    Diagnostic Hybrids, Inc.
    FEI Number
    1000122536
    Product Code
    OTR
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    November 3, 2015
    Terminated
    August 28, 2020
    Address
    2005 E State St, Ste 100, Athens, OH, 45701-2125

    Description

    MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. 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.

    Action

    Customers were notified via letter dated November 3, 2015, to review their inventory for the specified lots, discard the kits, and contact the recalling firm for replacement. Certificates of destruction were also provided to customers. For further questions, please call (740) 589-3300.

    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

    107 kits