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U.S. Department of Health and Human Services

Class 2 Device Recall E. coli/P. aeruginosa PNA FISH

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  Class 2 Device Recall E. coli/P. aeruginosa PNA FISH see related information
Date Initiated by Firm September 14, 2012
Date Posted October 22, 2012
Recall Status1 Terminated 3 on March 05, 2013
Recall Number Z-0116-2013
Recall Event ID 63199
Product Classification Kit, identification, enterobacteriaceae - Product Code JSS
Product AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa
Catalog Number : KT007

Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears of positive blood cultures containing Gram-negative rods. The E.coli/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia.
Code Information Lot Numbers: 01812A-US, 03412A-US and 00512A-EU  Exp Date: 12-2013
Recalling Firm/
Manufacturer		 Advandx Inc
400 Tradecenter
Ste 6990
Woburn MA 01801
Manufacturer Reason
for Recall		 Some strains of Pseudomonas putida cross-react with the P. aeruginosa PNA probe used in E. coli/P. aeruginosa PNA FISH (KT007) due to a sequence similarity resulting in a cross-reaction that may produce a red-positive signal
FDA Determined
Cause 2		 Process design
Action AdvanDx notified customers on September 14, 2012 by email along with a PDF file of the new package insert to each contact followed by written notification and a paper copy of the new package insert via FedEx courier. The notification described the product, problem and actions to be taken. The customers were instructed to destroy the package insert in any existing inventory of the kit and replace it with the enclosed package insert. "Note: All shipments of E. coli/P.aeruginosa PNA FISH as of September 14, 2012, will contain this new package insert." The customers were also instructed to complete and return the Acknowledgement of Receipt form to AdvanDX: Regulatory Affairs; 400 TradeCenter, Suite 6990, Woburn, MA 01801-7476; Fax to: +1 (781) 376-0111; bsc@advandx.com. If you have any questions or requests for further information, please contact AdvanDx Technical Support: US (Toll-Free): 1-866-376-0009, techsupport@advandx.com.
Quantity in Commerce 33 units
Distribution Worldwide distribution: USA (nationwide) including: CA, FL, IL, MI, and NJ; and country of: Great Britain.
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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