BEUDAMED
    FDA Enforcement Class II Terminated

    Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.

    Recall: Z-1947-2015 · Reported July 8, 2015

    Enforcement

    Recall Number
    Z-1947-2015
    Event ID
    71475
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BioMerieux SA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 8, 2015
    Initiation Date
    June 12, 2015
    Classification Date
    July 1, 2015
    Termination Date
    August 1, 2017
    Address
    Chemin De L'Orme, Marcy L'Etoile, N/A, France

    Description

    Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.

    Reason

    QC results were out of range resulting in false resistant strains.

    Code Info

    1002774320, 1002377890, 1002590470, 1002775330, 1002379610

    Distribution

    Worldwide Distribution - USA (nationwide) to the states of AL, AR, CA, CO, FL, GA, IL, IN, KY, MD, MI, MN, MO, NE, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, WV and WI., and to the countries of: Austria, Australia, Canada, Switzerland, Germany, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, Netherlands, Poland, Sweden, Thailand, Turkey, Saudi Arabia, Philippines, Slovenia, Kuwait, Brazil, Chile, Czech Republic, Algeria, South Africa, Kosovo, Costa Rica, Belarus, Guam, Honduras and Vietnam.

    Quantity

    674