AdvanDx GNR Traffic Light PNA FISH — Class II medical device recall Z-0112-2013
Terminated recall by Advandx Inc, reported 2012-10-31, distributed nationwide. GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva
| Recall number | Z-0112-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advandx Inc, Woburn, MA, United States |
| Recall initiated | 2012-09-14 |
| Classified | 2012-10-22 |
| Reported by FDA | 2012-10-31 |
| Terminated | 2013-03-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, DE, DK, FI, GB, IT |
| Quantity | 187 kits |
| Pathogens | pseudomonas |
| Lot numbers | 00712A-EU, 01212A-EU, 02012A-US, 0812A-US |
| Model numbers | KT011 |
| Expiration dates | 2012-04, 2013-12, 2014-04 |
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.
Reason for recall
GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0112-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.