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U.S. Department of Health and Human Services

Class 2 Device Recall BD Phoenix" Automated Microbiology System ID/AST Panels

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  Class 2 Device Recall BD Phoenix" Automated Microbiology System ID/AST Panels see related information
Date Initiated by Firm May 14, 2010
Date Posted November 15, 2010
Recall Status1 Terminated 3 on November 29, 2010
Recall Number Z-0366-2011
Recall Event ID 57001
510(K)Number K021954  
Product Classification System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
Product BD Phoenix" ID/AST Panels, Item # PMIC/ID-107, Catalog number 448607, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA (800) 638-8663***
Code Information Lot 0083198 Exp 03/31/2011
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks MD 21152-0999
For Additional Information Contact Kim Cartier
410-316-4000
Manufacturer Reason
for Recall		 The diagnostic reagent packaging may not be completely sealed, which may cause substrate degradation, and produce incorrect test results, including false positive and false negative results.
FDA Determined
Cause 2		 Packaging process control
Action BD Diagnostic Systems issued an "Urgent Product Recall" letter dated May 2010 to direct accounts, identifying the affected product, potential impact, and actions to be taken by the customer. Accounts were requested to respond by returning the enclosed reply form indicating the number of replacements needed for the affected product to be discarded. For assistance iwth replacements, contact BD Customer Service at 800 675-0908. For other inquiries, contact BD Technical Services at 1 800-638-8663.
Quantity in Commerce 1675 units
Distribution Nationwide Distribution: To direct accounts in CA, MD, NJ, PA. and WI.
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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