BEUDAMED
    FDA Recall Terminated

    Becton Dickinson Phoenix Update Disks (PUD), catalog # 441107/ 448047, component of BD automated microbiology system, and used with BD Gram Positive MIC or MIC/ID panels. Product Usage: The Phoenix Update Disk (PUD) delivers substrate and drug specific information to be used by the BD Phoenix instrument software in determining organism identification and susceptibility results. Information contained in the PUD does not change instrument functionality or features.

    Recall: Z-1658-2012 · Initiated April 10, 2012

    Recall

    Recall Number
    Z-1658-2012
    Event Number
    61692
    Firm
    Becton Dickinson & Co. BD Diagnostic Systems
    FEI Number
    1119779
    Product Code
    LON
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 10, 2012
    Posted
    May 24, 2012
    Terminated
    August 8, 2013
    Address
    7 Loveton Circle, Sparks, MD, 21152-0999

    Description

    Becton Dickinson Phoenix Update Disks (PUD), catalog # 441107/ 448047, component of BD automated microbiology system, and used with BD Gram Positive MIC or MIC/ID panels. Product Usage: The Phoenix Update Disk (PUD) delivers substrate and drug specific information to be used by the BD Phoenix instrument software in determining organism identification and susceptibility results. Information contained in the PUD does not change instrument functionality or features.

    Reason

    BD identified an increase in vancomycin-resistant strains that may exhibit erroneous results on all PMIC or PMIC/ID panels and could lead to ineffective treatment regimen in affected patients.

    Action

    Becton Dickinson (BD) sent an Urgent Field Correction Action letter dated April 2012 and an Update letter dated April 18, 2012 to all affected customers via e-mail and UPS overnight delivery. The letter identified the affected products, problem and actions to be taken. The letter provided specific workaround instructions for device users pending software upgrades. A BD Service Engineer will contact affected customers to arrange for the installation of the updated software when it becomes available. The letter included an Acknowledgement Form to be completed. For questions contact Technical Services at 800-638-8663.

    Distribution

    Worldwide Distribution - USA (nationwide) including the states of: AL, AR, AZ, CA, CO, CT ,DC ,FL , GA, IA, IL, IN, KY, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, AND WY. and the countries of Canada, Australia, Philippines, Thailand, Malaysia, India, New Zealand, Belgium, Singapore, Japan, Taiwan, China, Chile, Colombia, Korea, Brazil and Venezuela.

    Quantity

    3,454,993 total products (U.S.)