BEUDAMED
    FDA Recall Terminated

    BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems, BD Biosciences, San Jose, CA 95131.

    Recall: Z-0570-2008 · Initiated September 6, 2007

    Recall

    Recall Number
    Z-0570-2008
    Event Number
    45447
    Firm
    BD Biosciences
    FEI Number
    2916837
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 6, 2007
    Posted
    March 4, 2008
    Terminated
    April 15, 2008
    Address
    2350 Qume Dr, San Jose, CA, 95131-1807

    Description

    BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems, BD Biosciences, San Jose, CA 95131.

    Reason

    Inaccurate results: Software error results in inaccurate display result statistics. If the user adjusts the lymph gate or attractors in the Lab Report view without using the Manual Gate function (as described in the system manual), the statistic results will not be updated to match the adjusted gate.

    Action

    Becton Dickinson sent an Important Product Information letter by mail on 09/14/2007 informing customers of the need to follow the instructions for adjusting the lymph gate or attractors. The next software revision will alleviate this limitation.

    Distribution

    Worldwide Distribution - USA, Belgium, Brazil, Peru, Singapore, Canada, Jamaica, Chile, Ecuador, Hong Kong-China, Thailand, Mexico, Venezuela, Barbados, Philippines, Puerto Rico, Guatemala, Japan, Uruguay, Argentina, China, Trinidad and Tobago, Honduras, Australia, New Zealand, and India.

    Quantity

    1136 units