{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "124653",
      "product_res_number": "Z-0619-2014",
      "event_date_initiated": "2013-12-11",
      "event_date_posted": "2014-01-02",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-01-13",
      "res_event_number": "67069",
      "product_code": "JSS",
      "k_numbers": [
        "K123418"
      ],
      "product_description": "AdvanDx Gram-Negative QuickFISH BC.\n In-Vitro Diagnostic for the identification of Enterobacteriacae\nCatalog Number: QFGNRBC1-25\n\nGram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive blood cultures",
      "code_info": "Lot codes US: 04813C, 7413, 08113 exp. 2013-12  Lot codes OUS: 03113A 04213A 04813B",
      "firm_fei_number": "3004080598",
      "recalling_firm": "AdvanDx, Inc.",
      "address_1": "10a Roessler Rd",
      "city": "Woburn",
      "state": "MA",
      "postal_code": "01801-6208",
      "additional_info_contact": "781-376-0009",
      "reason_for_recall": "Kits incompatible with certain fluorescence microscope light sources",
      "root_cause_description": "Process design",
      "action": "AdvanDx  issued an email notification along with a PDF file of the new package insert  to each customer followed by written notification dated December 6, 2013 and a paper copy of the new package insert via Fed Ex courier. All customers received  an acknowledgement form to fill out and return to AdvanDx so that the effectiveness of the replacement can be evaluated. All existing inventory of Gram-Negative QuickFISH BC will be repackaged with the new package inert  Customers with questions were instructed to contact AdvanDx Technical Support at 1-866-376-0009 or techwupport@advandx.com.\nFor questions regarding this recall call 781-376-0009.",
      "product_quantity": "49 kits US; 17 kits OUS",
      "distribution_pattern": "Worldwide Distribution - USA including CA, IL, IN,  OH, NJ, MI , MO, NY, WI.  Internationally to Denmark.",
      "openfda": {
        "k_number": [
          "K852110",
          "K843571",
          "K833612",
          "K792058",
          "K791789",
          "K101558",
          "K782056",
          "K781368",
          "K150031",
          "K883558",
          "K851978",
          "K812286",
          "K082068",
          "K791932",
          "K811765",
          "K081309",
          "K894776",
          "K833613",
          "K854733",
          "K811434",
          "K860208",
          "K791991",
          "K926018",
          "K922588",
          "K834090",
          "K813164",
          "K771703",
          "K926002",
          "K830698",
          "K863603",
          "K912924",
          "K926017",
          "K092393",
          "K831672",
          "K852871",
          "K853009",
          "K781236",
          "K861774",
          "K813609",
          "K760790",
          "K123418",
          "K781367",
          "K081433",
          "K781427",
          "K092236",
          "K781816",
          "K830396",
          "K890626",
          "K924814"
        ],
        "device_name": "Kit, Identification, Enterobacteriaceae",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2660",
        "device_class": "1",
        "registration_number": [
          "3003750284",
          "9615754",
          "9680577",
          "9615755",
          "3009171251",
          "1924669"
        ],
        "fei_number": [
          "3003750284",
          "3007808629",
          "3008237827",
          "1000366600",
          "3006759904",
          "1924669"
        ]
      }
    }
  ]
}