BEUDAMED
    FDA Enforcement Class II Terminated

    VIDAS Testosterone, Ref 30418

    Recall: Z-2339-2017 · Reported July 19, 2017

    Enforcement

    Recall Number
    Z-2339-2017
    Event ID
    77292
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    bioMerieux, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 19, 2017
    Initiation Date
    May 15, 2017
    Classification Date
    July 11, 2017
    Termination Date
    June 11, 2020
    Address
    100 Rodolphe St, Durham, NC, 27712-9402, United States

    Description

    VIDAS Testosterone, Ref 30418

    Reason

    Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone.

    Code Info

    Lots 1004878310 & 1005001080

    Distribution

    AR, CA, CO, GA, IL, IA, MI, MN, MT, NY, OK, TN, TX, WY, Columbia, Costa Rica, El Salvador, France, Hong Kong, Jordan, Nicaragua, Russian Fed., Sri Lanka, Sweden, Ukraine

    Quantity

    742