BEUDAMED
    FDA Recall Terminated

    bioMerieux BacT/ALERT SN Anaerobic Culture Bottle-REF 259790

    Recall: Z-0243-2007 · Initiated August 17, 2006

    Recall

    Recall Number
    Z-0243-2007
    Event Number
    36239
    Firm
    bioMerieux, Inc.
    FEI Number
    3002769706
    Product Code
    MDB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 17, 2006
    Posted
    December 5, 2006
    Terminated
    December 8, 2009
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    bioMerieux BacT/ALERT SN Anaerobic Culture Bottle-REF 259790

    Reason

    Recovery Compromised-during manufacturing ambient air (including oxygen) was inadvertently introduced into the culture bottles, changing their reduction/oxidation potential thus leading to a compromised recovery of some obligate anaerobes and longer detection times.

    Action

    Affected Customers were notified of this recall on August 18, 2006 and August 21, 2006 via phone and instructed to destroy product remaining in stock.

    Distribution

    Nationwide Distribution ---- including states of AL, CA, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, MT, NC, NE, NJ, NY, OH, PA, RI, TX, VA, WA, WI, and WV.

    Quantity

    34,440