BEUDAMED
    FDA Recall Terminated

    BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.

    Recall: Z-0738-2013 · Initiated December 25, 2012

    Recall

    Recall Number
    Z-0738-2013
    Event Number
    64054
    Firm
    bioMerieux, Inc.
    FEI Number
    3002769706
    Product Code
    MDB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 25, 2012
    Posted
    January 25, 2013
    Terminated
    June 3, 2014
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.

    Reason

    BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.

    Action

    bioMerieux sent an "URGENT PRODUCT REMOVAL NOTICE" and Acknowledgement Form on January 4, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your local bioMerieux Customer Service Representative for additional assistance.

    Distribution

    Worldwide Distribution.USA including the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, KY, LA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WI, and WV, and the countries of China, Curacao and Japan.

    Quantity

    1690 cases