{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Woburn",
      "address_1": "400 Tradecenter",
      "reason_for_recall": "GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva",
      "address_2": "Ste 6990",
      "product_quantity": "187 kits",
      "code_info": "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",
      "center_classification_date": "20121022",
      "distribution_pattern": "Worldwide Distribution-USA (nationwide) and the countries of Austria, Denmark, Italy, Germany, Finland, and UK.",
      "state": "MA",
      "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.",
      "report_date": "20121031",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Advandx Inc",
      "recall_number": "Z-0112-2013",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "63215",
      "termination_date": "20130305",
      "recall_initiation_date": "20120914",
      "postal_code": "01801",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}