Advandx Inc: Medical Device Recall in 2012 - (Recall #: Z-0112-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 14, 2012

Date Posted: October 31, 2012

Recall Number: Z-0112-2013

Event ID: 63215

Reason for Recall:

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

Status: Terminated

Product Quantity: 187 kits

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.

Voluntary or Mandated:

Voluntary: Firm initiated