BEUDAMED
    FDA Recall Terminated

    VIDAS Testosterone, Ref 30418

    Recall: Z-2339-2017 · Initiated May 15, 2017

    Recall

    Recall Number
    Z-2339-2017
    Event Number
    77292
    Firm
    bioMerieux, Inc.
    FEI Number
    3002769706
    Product Code
    CDZ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 15, 2017
    Posted
    June 29, 2017
    Terminated
    June 11, 2020
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    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.

    Action

    An Urgent Product Safety Notice was sent on 5/15/2017 to consignees. The Notice requested that they discontinue use and discard any remaining inventory of the product, and to identify any possible falsely over estimated results and determine appropriate actions if relevant. The Notice also included a response form to be returned to Biomerieux.

    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