{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "42813",
      "product_res_number": "Z-0320-06",
      "event_date_initiated": "2005-10-14",
      "event_date_posted": "2005-12-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-01-29",
      "res_event_number": "33957",
      "product_code": "NJT",
      "product_description": "EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4011",
      "code_info": "K4011: Lots 035196, 055032, 075115",
      "firm_fei_number": "2022180",
      "recalling_firm": "Dakocytomation California Inc",
      "address_1": "6392 Via Real",
      "city": "Carpinteria",
      "state": "CA",
      "postal_code": "93013-2921",
      "additional_info_contact": "Scot D. Kinghorn\n805-566-5478",
      "reason_for_recall": "This recall has been initiated due to a formulation error in the EnVision+ visualization reagent.",
      "root_cause_description": "Other",
      "action": "Notification letter dated October 14, 2005 was sent by certified mail to cosignees instructing dosposal of product.",
      "product_quantity": "Lots 035196=163, 055032=168 &, 075115=124",
      "distribution_pattern": "Nationwide to: AK, AL, AZ, CA, CO, CT,  DC, FL, GA, HI, IA, IL, IN, KS,  KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH,  OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV.\nWorldwide to: Argentina, Bermuda, Brazil, Canada, Costa Rica, Denmark, Japan, Mexico, New Zealand, and Uruguay.",
      "openfda": {
        "registration_number": [
          "3017379203",
          "3015614371",
          "3014429566",
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        "fei_number": [
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          "3015614371",
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          "3015258926",
          "1000125183",
          "3027582128",
          "3013043616",
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        ],
        "device_name": "Immunohistochemistry Reagents And Kits",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.1860",
        "device_class": "1"
      }
    }
  ]
}