{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "139936",
      "product_res_number": "Z-0220-2016",
      "event_date_initiated": "2015-09-04",
      "event_date_posted": "2015-11-05",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-04-25",
      "res_event_number": "72097",
      "product_code": "LDT",
      "product_description": "EnVision FLEX/HRP visualization reagent found in the following kits:\nEnVision FLEX, High pH (Link)\nEnVision FLEX+, Mouse, High pH (Link)\nEnVision FLEX Mini Kit, High pH (Link)\nEnVision FLEX, High pH (Dako Omnis)\n\nMulti-component, sealed package. For in vitro diagnostic use.",
      "code_info": "Item No.: K800021-2, K800221-2, K802321-2 (Link) K801021-2, K801221-2, K802421-2 (AS/AS+) GV80011-2, GV82311-2 (Dako Omnis)  Catalog/Model No.: K8000 K8002 K8023 GV800  SM802 EnVision FLEX / HRP Lot 20019374 used in: Envision FLEX, High pH (link) Lot No.: 20019097, 20020777, 20021381 Envision FLEX+, Mouse, High pH (link) Lot No.: 20019103, 20019113, 20020772 EnVision FLEX Mini Kit, High pH (Link) Lot No.: 20021362  DM 842 EnVision FLEX / HRP (Dako Omnis) Lot 20019013 used in: EnVision FLEX, High pH (Dako Omnis) Lot No.: 20019102",
      "firm_fei_number": "2022180",
      "recalling_firm": "Dako North America Inc.",
      "address_1": "6392 Via Real",
      "city": "Carpinteria",
      "state": "CA",
      "postal_code": "93013-2921",
      "additional_info_contact": "805-566-6655",
      "reason_for_recall": "There is a defect in one lot of a buffer, non-specific background staining that has, in some instances, interfered with interpretation of the staining results.",
      "root_cause_description": "Other",
      "action": "Dako sent an customer notification letter on September 4, 2015, to all affected customers via mail. The letter identified the product the problem and the action needed to be taken by the customer.\n\nThe customers/distributors are instructed in the Recall Notification Letters to 1) remove any unused kits bearing the affected lot numbers listed in their letter from diagnostic use 2) destroy any unused kits bearing the affect lot numbers listed in their letter, and 3) determine any possible impact of this change in performance on patient results from the affected lots.\n\nThe letter states actions should be taken within 10 days and that customers/distributors should confirm they have received the information by returning the attached, fully completed Device Recall Form and return it to Dako QA Vigilance by email at dako.dkvigilance@dako.com.\n\nThe firm lists on their letter for customers to contact their Dako representative in there are any questions. For further questions, call (805) 566-6655.",
      "product_quantity": "300 units",
      "distribution_pattern": "Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the states of :  TX, SD, CA, FL, MA, MD, WV, NC, OH, DE, MI, NJ, CO, HI, AR, NY, LA, GA, NV, RI, IL, OK, CT, MO, VA, and DC., and to the countries of : Canada, Brazil and Costa Rica.",
      "openfda": {}
    }
  ]
}