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.
This recall has been terminated (originally issued May 24, 2012).
- Recall Initiated
- April 10, 2012
- Posted
- May 24, 2012
- Terminated
- August 8, 2013
- Recall Number
- Z-1658-2012
- Quantity
- 3,454,993 total products (U.S.)
- Firm Location
- Sparks, MD
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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.
Lot / Code Info
BD Phoenix Update Disks (PUD) versions: 4.51 R, 4.56G, 4.61A, 4.65A, 4.71A, 4.75A, 4.81A, 4.85A, 4.91A, 5.11A, 5.15A, 5.21A
Root Cause
Nonconforming Material/Component
Action Taken
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.