AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa Catalog number: KT011. GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods observed on Gram stain. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth. The GNR Traffic Light PNA FISH assay is indicated for use as an aid in the diagnosis of coli, and/or K. pneumoniae, and/or P. aeruginosa bacteremia.
FDA Recall Z-0112-2013 · Posted 2012-10-22
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Recalling FirmAdvandx Inc
Recall StatusTerminated
Product CodeJSS
Date Initiated2012-09-14
Date Terminated2013-03-05
Product Quantity187 kits
Reason for Recall
GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva
Firm Action
AdvanDx sent a "GNR Traffic Light PNA FISH (KT011) Package Insert Replacement" letter dated September 14, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. All customers received an Acknowledgement Form to complete and return to AdvanDx so that the effectiveness of the replacement can be evaluated. Contact AdvanDx Technical Support at 1-866-376-0009 for questions regarding this notice.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Austria, Denmark, Italy, Germany, Finland, and UK.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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