BEUDAMED
    FDA Recall Terminated

    Bac T/ALERT 3D Combination Module

    Recall: Z-0613-05 · Initiated May 27, 2005

    Recall

    Recall Number
    Z-0613-05
    Event Number
    32377
    Firm
    BIOMERIEUX, INC.
    FEI Number
    3002769706
    Product Code
    MDB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 27, 2005
    Posted
    September 7, 2005
    Terminated
    September 21, 2006
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    Bac T/ALERT 3D Combination Module

    Reason

    A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric BAC T/ALERT PF bottle.

    Action

    Consignees were notified by letter on May 27, 2005.

    Distribution

    Nationwide, Argentina, Australia/N. Zealand, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Italy, Ivory Coast, Japan, Korea, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Sweden, Switzerland, Turkey, UK

    Quantity

    2,001 units