FDA Medical Device Recalls (openFDA)
Advandx Inc: 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.
- Recall number
- Z-0112-2013
- 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.
- Status
- Terminated
- Initiated
- 2012-09-14
- Posted
- 2012-10-22
- Terminated
- 2013-03-05
- Reason
- GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva
- 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
- 187 kits
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Austria, Denmark, Italy, Germany, Finland, and UK.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JSS
- Firm FEI
- 3004080598
- Firm city
- Woburn
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28