BEUDAMED
    FDA Recall Terminated

    bioMerieux, BacT/ALERT FA Culture Bottles, bioMerieux, Inc., Durham, NC 27704

    Recall: Z-0457-2008 · Initiated November 5, 2007

    Recall

    Recall Number
    Z-0457-2008
    Event Number
    45799
    Firm
    bioMerieux, Inc.
    FEI Number
    3002769706
    Product Code
    MDB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 5, 2007
    Posted
    January 4, 2008
    Terminated
    December 8, 2009
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    bioMerieux, BacT/ALERT FA Culture Bottles, bioMerieux, Inc., Durham, NC 27704

    Reason

    Duplicate Bottle Indentification -- Three lot numbers of BacT/ALERT FA Culture Bottles labels contained duplicate bottle identification (Bottle ID) barcode numbers. (Lots 1017685 and 1017788 contain the same series of Bottle ID's; Lot 1017693 contains duplicate Bottle ID's within the lot and may share Bottle ID's with both lots 1017685 and 1017788)

    Action

    bioMerieux notified all Consignees with a Urgent Product Recall Notice letter on 11/05/2007. They were instructed to examine their inventory to determine if they have any remaining inventory of the 3 affected lots. If they have any of these bottles they were instructed to stop using them and destroy all remaining inventory. A Customer Acknowledgement Form was attached to be completed and returned to bioMerieux via fax or mail. There were also instructions attached for the use of Generic Bottle Barcodes and Creating a Unique Bottle ID.

    Distribution

    Worldwide Distribution-USA including countries of Australia, Austria, Bangladesh, Brazil, Bulgaria, Byelorussia, Chile, China, Colombia, Croatia, Denmark, Dijbouti, Estonia, Federation of Russia, Finland, France, Germany, Greece, Guadeloupe, India, Israel, Italy, Korea, Kuwait, Martinique, Mexico, Netherlands, New Caledonia, Norway, Panama, Poland, Portugal, Reunion, Saudi Arabia, Serbia Montenegro, Slovenia, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vietnam.

    Quantity

    7,025