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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 Recall
AdvanDx EK/P. aeruginosa PNA FISH
see related information
Date Posted December 01, 2010
Recall Status1 Terminated on June 06, 2011
Recall Number Z-0491-2011
Recall Event ID 56997
Premarket Notification
510(K) Number
K092393 
Product Classification Kit, Identification, Enterobacteriaceae - 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, Massachusetts 01801-6208
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JSS and Original Applicant = ADVANDX, INC.
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