BEUDAMED
    FDA Recall Terminated

    BacT/ALERT FN Culture Bottles, Product Number 259793

    Recall: Z-1189-2007 · Initiated February 16, 2007

    Recall

    Recall Number
    Z-1189-2007
    Event Number
    38433
    Firm
    bioMerieux, Inc.
    FEI Number
    3002769706
    Product Code
    MBD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 16, 2007
    Posted
    August 22, 2007
    Terminated
    December 8, 2009
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    BacT/ALERT FN Culture Bottles, Product Number 259793

    Reason

    Microbial Contamination: Bacillus sp. contamination was detected in inoculated bottles.

    Action

    Consignees were notified by Urgent Product Recall letter on 02/19/2007. They were instructed to destroy any unused inventory of this product lot that they have on hand.

    Distribution

    Worldwide; USA, Austria, Bulgaria, Caledonia, China, Croatia, Curacao, Finland, France, Germany, Greece, Guadeloupe, Italy, Latvia, Mexico, Netherlands, Poland, Portugal, Spain, Saudi Arabia, Sultanate of Oman, Switzerland, Sweden, and United Kingdom

    Quantity

    2,403 cases (100 bottles per case)