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U.S. Department of Health and Human Services

Class 2 Device Recall BD Phoenix" Panel NMIC/ID123, Catalog 448723,

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  Class 2 Device Recall BD Phoenix" Panel NMIC/ID123, Catalog 448723, see related information
Date Initiated by Firm February 28, 2011
Date Posted March 30, 2011
Recall Status1 Terminated 3 on January 30, 2013
Recall Number Z-1847-2011
Recall Event ID 58066
510(K)Number K033458  
Product Classification System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
Product BD Phoenix" Panel NMIC/ID-123, Catalog # 448723, packaged 25 panels/carton, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA (800) 638-8663***

The BD Phoenix¿ Automated Microbiology System is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The Phoenix system provides results for most aerobic and facultative anaerobic Gram negative bacteria of human origin with the use of the NMIC/ID-123 panel type.
Code Information Lot 0223498 exp 8/31/2011
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks MD 21152-0999
For Additional Information Contact Kim Cartier
800-675-0908
Manufacturer Reason
for Recall		 In vitro diagnostic test kit is defective and may cause false positive or false negative results.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action BD Diagnostics Systems sent an Urgent Product Recall letter dated February 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinsue use of the affected product and discard any remaining packages. BD would issue replacements for the discarded material. Customers were instructed to complete the attached form whether or not they had any inventory remaining so that the firm may acknowledge receipt of this notification. Complete and fax the form to BD Regulatory Compliance to 410-316-4258. For further assistance contact BD Customer Service at 1-800-675-0908. For other inquiries, contact BD Technical Services at 1-800-638-8663.
Quantity in Commerce 377 cartons
Distribution Worldwide Distribution - USA including AZ, CA, FL, GA, MA, MD, NC, NY, PA, TX, WA, WI, and WY and the countries of The product was distributed to medical facilities nationwide and to foreign consignees in Argentina, Brazil, Chile, and Mexico.
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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