BEUDAMED
    FDA Enforcement Class III Terminated

    Etest¿ Ceftaroline (CPT32) WW B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.

    Recall: Z-0230-2015 · Reported November 26, 2014

    Enforcement

    Recall Number
    Z-0230-2015
    Event ID
    69579
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomerieux
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 26, 2014
    Initiation Date
    October 16, 2014
    Classification Date
    November 19, 2014
    Termination Date
    November 30, 2017
    Address
    69280 Marcy, N/A, Letoile, N/A, N/A, France

    Description

    Etest¿ Ceftaroline (CPT32) WW B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.

    Reason

    The products have a wrong expiration date on their labeling, 5 years instead of 2 years.

    Code Info

    Ref #537500, Lot #1003160540, Right Expiry date: 27-APR-2016

    Distribution

    Worldwide Distribution-US (nationwide) including DC and the states of AL, AK, AR, AZ, CA, CO, DE, FL, GA, IA, IN, KY, MA, MD, MI, MO, NC, NE, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, and the countries of Australia, Austria, China, Czech Republic, France, Germany, India, Italy, Japan, Netherlands, Poland, Portugal, Switzerland, Sweden, Turkey, United Kingdom, Egypt, Pakistan, Slovenia and Uruguay.

    Quantity

    652 devices