Advandx Inc recalls AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebs

Recalled October 31, 2012 · FDA recall Z-0112-2013 · Advandx

Hazard

GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva · FDA Class II

Units

187 kits

Sold at

Worldwide Distribution-USA (nationwide) and the countries of Austria, Denmark, Italy, Germany, Finland, and UK.

Description

GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva

Product

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.

Manufacturer(s)

Advandx Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →