Device 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.
Z-0112-2013
Product summary
- Firm
- Advandx Inc
- Event
- Event 63215
- Status
- Terminated
- Classification
- Class II
- Quantity
- 187 kits
- Official record key
device-enforcement:Z-0112-2013
Official wording
Reason: GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva
Code information: Lot Numbers: 02012A-US Exp. Date: 4-2014; 0812A-US Exp. Date: 12-2013; 01212A-EU Exp. Date: 4-2012 00712A-EU Exp. Date: 12-2013
Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Austria, Denmark, Italy, Germany, Finland, and UK.
Derived failure modes
-
Unknown
GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva