BEUDAMED
    FDA Recall Terminated

    CellQuest Pro SW, version 4.0.2. and later; Becton Dickinson, San Jose, CA 95131 CellQuest Pro software allows you to acquire and analyze data from your flow cytometer on a Macintosh computer.

    Recall: Z-1845-2011 · Initiated September 7, 2007

    Recall

    Recall Number
    Z-1845-2011
    Event Number
    57613
    Firm
    BD Biosciences, Systems & Reagents
    FEI Number
    2916837
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 7, 2007
    Posted
    March 30, 2011
    Terminated
    March 31, 2011
    Address
    2350 Qume Dr, San Jose, CA, 95131-1812

    Description

    CellQuest Pro SW, version 4.0.2. and later; Becton Dickinson, San Jose, CA 95131 CellQuest Pro software allows you to acquire and analyze data from your flow cytometer on a Macintosh computer.

    Reason

    Results and gates could be mismatched if you utilize the undo function to undo a gate that was deleted.

    Action

    Important Product Information letters, dated September 2007, were sent the week of 9/14/2001 via Federal Express to all affected customers. The letters identified the affected product along with the reason for recall. The letter states that "as long as customers do not use the Undo function to undo a gate deletion, the software can be used with full functionality." The letter also states that BD will change the issue in the next software version. If customers believe that they may have analyzed sample files by utilizing the Undo function, then it is recommended that the sample files be re-analyzed. If customers need more information they should contact the Customer Support Center at 877-232-8995.

    Distribution

    Worldwide Distribution

    Quantity

    4552