{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "113037",
      "product_res_number": "Z-0112-2013",
      "event_date_initiated": "2012-09-14",
      "event_date_posted": "2012-10-22",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-03-05",
      "res_event_number": "63215",
      "product_code": "JSS",
      "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 \nCatalog number: KT011.\n\nGNR 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.",
      "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",
      "firm_fei_number": "3004080598",
      "recalling_firm": "Advandx Inc",
      "address_1": "400 Tradecenter",
      "address_2": "Ste 6990",
      "city": "Woburn",
      "state": "MA",
      "postal_code": "01801",
      "reason_for_recall": "GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva",
      "root_cause_description": "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.",
      "product_quantity": "187 kits",
      "distribution_pattern": "Worldwide Distribution-USA (nationwide) and the countries of Austria, Denmark, Italy, Germany, Finland, and UK.",
      "openfda": {
        "k_number": [
          "K782056",
          "K771703",
          "K890626",
          "K781368",
          "K781236",
          "K861774",
          "K830396",
          "K081309",
          "K833612",
          "K926002",
          "K760790",
          "K813164",
          "K854733",
          "K833613",
          "K853009",
          "K924814",
          "K813609",
          "K781816",
          "K092236",
          "K082068",
          "K830698",
          "K926018",
          "K812286",
          "K101558",
          "K123418",
          "K852871",
          "K894776",
          "K791789",
          "K781427",
          "K811765",
          "K150031",
          "K834090",
          "K781367",
          "K883558",
          "K912924",
          "K926017",
          "K852110",
          "K811434",
          "K831672",
          "K863603",
          "K081433",
          "K843571",
          "K922588",
          "K792058",
          "K791932",
          "K791991",
          "K092393",
          "K860208",
          "K851978"
        ],
        "device_name": "Kit, Identification, Enterobacteriaceae",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2660",
        "device_class": "1",
        "registration_number": [
          "3009171251",
          "3003750284",
          "1924669",
          "9615755",
          "9680577",
          "9615754"
        ],
        "fei_number": [
          "3003750284",
          "3008237827",
          "3006759904",
          "1000366600",
          "1924669",
          "3007808629"
        ]
      }
    }
  ]
}