{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "217913",
      "product_res_number": "Z-1369-2026",
      "event_date_initiated": "2025-12-15",
      "event_date_posted": "2026-02-13",
      "recall_status": "Open, Classified",
      "res_event_number": "98219",
      "product_code": "CGF",
      "k_numbers": [
        "K935013"
      ],
      "product_description": "Estrone RIA, REF: DSL8700",
      "code_info": "UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)",
      "firm_fei_number": "3003385757",
      "recalling_firm": "Immunotech A.S.",
      "address_1": "Radiova 1 1 radiova",
      "city": "Prague 10",
      "country": "Czech Republic",
      "reason_for_recall": "The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issue occur.",
      "root_cause_description": "Equipment maintenance",
      "action": "On 12/15/2025, Beckman Coulter emailed recall notices to customers who were informed of the following:\n\n1) Discard any remaining inventory of affected lots per your laboratory protocols and ask for replacement.\n2) Firm recommends sharing the content of this letter with your laboratory and/or medical director.\n3) If you have forwarded any of the affected products to another laboratory, provide them a copy of this letter.\n4) Complete and return the response form via email to QACZ@beckman.com\n\nQuestions can be sent to the firm via email at imunochem@beckman.com",
      "product_quantity": "160",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.",
      "openfda": {
        "device_name": "Radioimmunoassay, Estrone",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1280",
        "device_class": "1",
        "k_number": [
          "K833406",
          "K970915",
          "K864966",
          "K935013"
        ],
        "registration_number": [
          "3007118747",
          "3009335633",
          "2020726",
          "2245285",
          "1222302",
          "2133982",
          "3002800697",
          "8010132",
          "2029372",
          "3007361513",
          "3022178699",
          "3003385757"
        ],
        "fei_number": [
          "3007118747",
          "1000121039",
          "1000306617",
          "3000717645",
          "3009335633",
          "2020726",
          "2245285",
          "3002800697",
          "3002806808",
          "3007361513",
          "3022178699",
          "3003385757"
        ]
      }
    }
  ]
}