BEUDAMED
    FDA Recall Terminated

    BacT/ALERT 3D 60 Systems Software, Blood Culturing System

    Recall: Z-0776-2007 · Initiated August 14, 2006

    Recall

    Recall Number
    Z-0776-2007
    Event Number
    36826
    Firm
    bioMerieux, Inc.
    FEI Number
    3002769706
    Product Code
    MDB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 14, 2006
    Posted
    May 3, 2007
    Terminated
    December 8, 2009
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    BacT/ALERT 3D 60 Systems Software, Blood Culturing System

    Reason

    Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems.

    Action

    Consignees were notified via A Field Corrective Action Notification on/about 10/18/2006. A second notification was sent on October 31, 2006.

    Distribution

    Worldwide, including USA, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dutch Antilles, Egypt, Ecuador, Estonia, Faeroe Islands, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Korea, Latvia, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania , Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.

    Quantity

    10790 units, total for all models