Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AdvanDx GNR Traffic Light PNA FISH Recalled by Advandx Inc Due to GNR Traffic Light PNA Fish may have false...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Advandx Inc directly.
Affected Products
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.
Quantity: 187 kits
Why Was This Recalled?
GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Advandx Inc
Advandx Inc has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report