CLASS II Device recall · Reported 31 Oct 2012 · FDA Enforcement Report
GNR Traffic Light PNA FISH, In Vitro Diagnostic recalled by Advandx
Advandx is recalling AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit, distributed nationwide in the US. The recall was initiated on 14 Sep 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0112-2013
- FDA event ID
- 63215
- Recalling firm
- Advandx, Woburn, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Sep 2012
- FDA classified
- 22 Oct 2012
- Reported
- 31 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- E. coli
- Device type
- Test Kits & Diagnostics
Timeline
| 14 Sep 2012 | Recall initiated by company | |
| 22 Oct 2012 | Classified by FDA | +38 days |
| 31 Oct 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva
Some strains of E. coli, such as O157:H7, produce a toxin that can cause severe stomach cramps, bloody diarrhea and, in a small number of cases, kidney failure.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution-USA (nationwide) and the countries of Austria, Denmark, Italy, Germany, Finland, and UK.
Questions about this recall
Is GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for recalled?
Yes. Advandx recalled GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for on 14 Sep 2012. The recall is Class II and its status is Terminated. Recall number Z-0112-2013.
Why was it recalled?
GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva
Which lots are affected?
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
Where was it sold?
Worldwide Distribution-USA (nationwide) and the countries of Austria, Denmark, Italy, Germany, Finland, and UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Advandx
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
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