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U.S. Department of Health and Human Services

Class 2 Device Recall BD Phoenix System software update disk

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  Class 2 Device Recall BD Phoenix System software update disk see related information
Date Initiated by Firm April 10, 2012
Date Posted May 24, 2012
Recall Status1 Terminated 3 on August 08, 2013
Recall Number Z-1658-2012
Recall Event ID 61692
510(K)Number K030677  
Product Classification System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
Product 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.
Code Information 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
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks MD 21152-0999
For Additional Information Contact Kimberly Cartier
410-316-4418
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
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.
Quantity in Commerce 3,454,993 total products (U.S.)
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LON and Original Applicant = BECTON, DICKINSON & CO.
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