BEUDAMED
    FDA Recall Terminated

    Etest Ceftaroline (CPT32) WWB100. Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.

    Recall: Z-0231-2015 · Initiated October 16, 2014

    Recall

    Recall Number
    Z-0231-2015
    Event Number
    69579
    Firm
    Biomerieux 69280 Marcy Letoile France
    FEI Number
    1000611339
    Product Code
    JWY
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    October 16, 2014
    Posted
    November 19, 2014
    Terminated
    November 30, 2017

    Description

    Etest Ceftaroline (CPT32) WWB100. 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.

    Action

    Consignees of bioMrieux, impacted by the identified issue, were notified of the FSCA and corrective action (FSCA notification) electronically on October 16th, 2014. Additionally, the bioMrieux United States subsidiary notified US consignees of the FSCA notification via FedEx on October 23rd, 2014.

    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