BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1947-2015 · Initiated June 12, 2015

    Recall

    Recall Number
    Z-1947-2015
    Event Number
    71475
    Firm
    BioMerieux SA Chemin De L'Orme Marcy L'Etoile France
    FEI Number
    1000611339
    Product Code
    JWY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 12, 2015
    Posted
    July 1, 2015
    Terminated
    August 1, 2017

    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.

    Action

    BioMerieux sent an Urgent Product Removal Notices dated June 12, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Required actions: Please distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product. Discontinue using and discard any remaining inventory of Etest CEFOTAXIME CT 256 lots reported in table 1. Discuss any concerns you may have regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action. Complete and return the Acknowledgement Form in Attachment A by Fax to confirm receipt of this notice and to request product replacement. bioMrieux is committed to providing our customers with the highest quality product possible. We sincerely apologize for any inconvenience that this may have caused you. If you require additional assistance or have any questions, please contact your local bioMrieux Clinical Customer Service organization at (800) 682-2666.

    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