Z-0112-2013Class II

AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia...

Name: Z-0112-2013 AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia...
Creator: Advandx Inc
Published: 2012-09-14
License: https://open.fda.gov/license/

Advandx, Inc. / initiated 2012-09-14 / Terminated / root cause: design

FDA source

Advandx Inc began a recall of AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas... on 2012-09-14. FDA classified it as Class II and gives the reason as "GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0112-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-14
Posted: 2012-10-22
Terminated: 2013-03-05
Recalling firm: Advandx, Inc.
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.
Product code: JSS Kit, Identification, Enterobacteriaceae
Reason for recall: GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva
Root cause tag: design
FDA root cause: Device Design
Action: AdvanDx sent a "GNR Traffic Light PNA FISH (KT011) Package Insert Replacement" letter dated September 14, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. All customers received an Acknowledgement Form to complete and return to AdvanDx so that the effectiveness of the replacement can be evaluated. Contact AdvanDx Technical Support at 1-866-376-0009 for questions regarding this notice.
Quantity in commerce: 187 kits
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Austria, Denmark, Italy, Germany, Finland, and UK.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0112-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0112-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-22

Product code JSS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)