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U.S. Department of Health and Human Services

Class 2 Device Recall AdvanDx EK/P. aeruginosa PNA FISH

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  Class 2 Device Recall AdvanDx EK/P. aeruginosa PNA FISH see related information
Date Initiated by Firm October 08, 2010
Date Posted December 01, 2010
Recall Status1 Terminated 3 on June 06, 2011
Recall Number Z-0491-2011
Recall Event ID 56997
510(K)Number K092393  
Product Classification Kit, identification, enterobacteriaceac - Product Code JSS
Product AdvanDx EK/P. aeruginosa PNA FISH- Culture Identification Kit for identification of E. coli and/or K. pneumoniae and P. aeruginosa bacteremia (In-Vitro Diagnostic)
Catalog number: KT008
EK/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and/or Klebsiella pneumoniae and Pseudomonas aeruginosa on smears made from positive blood cultures containing Gram-negative rods.
Code Information All codes
Recalling Firm/
Manufacturer		 AdvanDx, Inc.
10a Roessler Rd
Woburn MA 01801-6208
For Additional Information Contact
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 sent an e-mail notification along with a PDF file to all customers on October 8, 2010, followed by written notification dated October 6, 2010. The letter identified the product, the problem, and the action the customers should take. Customers were instructed to replace the package insert(s) included with any kits in their inventory with the enclosed package insert(s). Customers were also instructed to fill out the enclosed Acknowledgement of Receipt Form and return it to AdvanDx to confirm that they received the new package insert. For questions regarding this recall contact AdvanDx Technical Support at 1-888-376-0009.
Quantity in Commerce 27 kits
Distribution Worldwide Distribution - USA including IL, MI, NY, and PA and the country of Denmark
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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