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U.S. Department of Health and Human Services

Class 2 Device Recall Phoenix

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  Class 2 Device Recall Phoenix see related information
Date Initiated by Firm October 29, 2004
Date Posted November 30, 2004
Recall Status1 Terminated 3 on January 31, 2005
Recall Number Z-0268-05
Recall Event ID 30445
Product Classification System, Test, Automated, Antimicrobial Susceptibility, Short Incubation - Product Code LON
Product BD¿ Phoenix¿ ID/AST panels, catalog numbers 448007, 448008, 448400, 448452, 448459, 448600, and 448708, packaged in cartons of 25 panels.
Code Information Lots: 3316699 11/30/2004 4146868 05/31/2005 4063959 03/31/2005 4231466 08/31/2005 3288384 10/31/2004 3316697 11/30/2004 4035990 02/28/2005 4063276 03/31/2005 4133618 05/31/2005 4203249 07/31/2005 4209161 08/31/2005 4245919 09/30/2005 4231472 08/31/2005 4181008 07/31/2005 4224731 08/31/2005 4231473 08/31/2005 4224708 08/31/2005 
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information Contact BD Customer Service
800-675-0908
Manufacturer Reason
for Recall		 The foil pouch containing an in vitro diagnostic test kit for bacteria identification in patient samples may be defective and cause incorrect patient results.
FDA Determined
Cause 2		 Other
Action BD Diagnostic Systems notified end users by letter dated October 2004. The firm''s sales representatives delivered the letters initially on 10/29/04. The letter advises end users to examine identified lots for defects using a diagram provided with the notification and discard any suspect product for replacement. A response form is included with the notification.
Distribution Product was sold to direct accounts nationwide and to the firm''s affiliate distributors worldwide.
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.
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