Reported Oct 31, 2012 · Terminated
AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or…
Advandx Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Advandx Inc · 400 Tradecenter · Woburn, MA · 01801
Is this the product you have?
- 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 numberKT011. 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
- Lot codes and dates
- Lot Numbers02012A-US Exp
- Date
4-20140812A-US Exp
- Date
12-201301212A-EU Exp
- Date4-2012 00712A-EU Exp
- Date12-2013
- Amount recalled
- 187 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva
This product could cause temporary or reversible health problems — stop using it.
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