BEUDAMED
    FDA Recall Terminated

    BD FACS Sample Prep Assistant II, Part Number: 337170; Product is manufactured and distributed by BD Biosciences, San Jose, CA 95131

    Recall: Z-0526-2008 · Initiated October 2, 2007

    Recall

    Recall Number
    Z-0526-2008
    Event Number
    45880
    Firm
    BD Biosciences
    FEI Number
    2916837
    Product Code
    GKI
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    October 2, 2007
    Posted
    April 10, 2008
    Terminated
    December 13, 2010
    Address
    2350 Qume Dr, San Jose, CA, 95131-1807

    Description

    BD FACS Sample Prep Assistant II, Part Number: 337170; Product is manufactured and distributed by BD Biosciences, San Jose, CA 95131

    Reason

    Mixing Performance: SPA II devices manufactured with the affected product motor control board may exhibit suboptimal mixing performance.

    Action

    On 10/1/07, all consignees were notified via Important Product Information letter and also an on-site visit by the firm's sales representative. The letter informed users of the affected product and provided instructions on the recall. For additional concerns or questions contact BD Customer Support Center at 1-877-232-8995.

    Distribution

    Worldwide Distribution --- USA including states of: NJ, IL, TX, PA, NY, MN, and AZ, and countries of Australia, Belgium, Hong Kong, Trinidad and Tobago. Australia, Belgium, Hong Kong, Trinidad and Tobago.