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U.S. Department of Health and Human Services

Class 2 Device Recall AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit

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  Class 2 Device Recall AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit see related information
Date Initiated by Firm October 06, 2010
Date Posted November 29, 2010
Recall Status1 Terminated 3 on June 06, 2011
Recall Number Z-0490-2011
Recall Event ID 57002
510(K)Number K092236  
Product Classification Kit, identification, enterobacteriaceae - Product Code JSS
Product AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit for the diagnosis of E. coli and/or P. aeruginosa bacteremia
Catalog Number: KT007
Code Information Lot Codes Exp date 04310A-U8 2012-08; 03610A-U8 2012-08 ; 02110A-EU 2011-05 ; 02010A-US 2011-05 ; 00410A-US 2011-05 ; 00110A-US 2010-11 ; 07509A-EU 2010-11 ; 07009A-US 2010-11 ; 06409A-US 2010-11 ; 02909A-EU 2010-02 ; 02309A-US 2010-02; 
Recalling Firm/
Manufacturer		 AdvanDx, Inc.
10a Roessler Rd
Woburn MA 01801-6208
For Additional Information Contact SAME
781-376-0009
Manufacturer Reason
for Recall		 Strains of Acinetobacter radioresistens cross-react with both E. coli/P. aeruginosa PNA FISH and EK/P. aeruginosa PNA FISH to produce a false positive red signal.
FDA Determined
Cause 2		 Device Design
Action AdvanDx issued a customer letter dated October 6, 2010 with a PDF file of a new package insert and an acknowledgement form to fill out and return to AdvanDx. Customers were instructed to replace the package insert in any existing inventory with the enclosed package insert. Customers can contact AdvanDx technical support about this action at 1-866-376-0009.
Quantity in Commerce 260 units
Distribution Worldwide Distribuition: Throughtout the US, and to the countries of Denmark, Italy, Sweden, and UK.
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 = JSS and Original Applicant = ADVANDX, INC.
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