{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Carpinteria",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "72097",
      "recalling_firm": "Dako North America Inc.",
      "address_1": "6392 Via Real",
      "address_2": "N/A",
      "postal_code": "93013-2921",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "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.",
      "recall_number": "Z-0220-2016",
      "product_description": "EnVision FLEX/HRP visualization reagent found in the following kits:  EnVision FLEX, High pH (Link)  EnVision FLEX+, Mouse, High pH (Link)  EnVision FLEX Mini Kit, High pH (Link)  EnVision FLEX, High pH (Dako Omnis)    Multi-component, sealed package. For in vitro diagnostic use.",
      "product_quantity": "300 units",
      "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.",
      "recall_initiation_date": "20150904",
      "center_classification_date": "20151105",
      "termination_date": "20160425",
      "report_date": "20151111",
      "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"
    }
  ]
}