BEUDAMED
    FDA Enforcement Class II 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 · Reported February 6, 2013

    Enforcement

    Recall Number
    Z-0738-2013
    Event ID
    64054
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    bioMerieux, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 6, 2013
    Initiation Date
    December 25, 2012
    Classification Date
    January 25, 2013
    Termination Date
    June 3, 2014
    Address
    100 Rodolphe St, Durham, NC, 27712-9402, United States

    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.

    Code Info

    Catalog Number: 259789, Lots/Batch: 1031866

    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