{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "214444",
      "product_res_number": "Z-2336-2025",
      "event_date_initiated": "2025-06-12",
      "event_date_posted": "2025-08-18",
      "recall_status": "Open, Classified",
      "res_event_number": "97090",
      "product_code": "CGF",
      "k_numbers": [
        "K935013"
      ],
      "product_description": "Estrone RIA Catalog Number DSL8700\nUDI Code: 15099590211615\n\nEstrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma.",
      "code_info": "Catalog Number DSL8700\nUDI Code: 15099590211615\nSerial/Lot Numbers:\n241014D\n241111C\n241209C\n241209D\n250106C\n250106D\n250203C",
      "firm_fei_number": "3003385757",
      "recalling_firm": "Immunotech A.S.",
      "address_1": "Radiova 1 1 radiova",
      "city": "Prague 10",
      "country": "Czech Republic",
      "reason_for_recall": "Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient results which might cause Permanent injury of Remote probability. Only in some (very rare) cases may the issue occur.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On 06/12/2025, the firm sent an \"URGENT MEDICAL DEVICE RECALL\" Letter to customers informing them that Beckman Coulter determined that the Estrone RIA kit might be affected by an isolated coated tubes inhomogeneity issue causing falsely elevated results or falsely decreased results.\n\nCustomers are instructed to:\nBeckman Coulter recommends sharing the content of the Recall Letter with their laboratory and/or medical director regarding the need to review previous patient test results. Note- All affected product have expired (expiry dates 12/31/2024 thru 04/22/2025)\n\nFor questions, contact Customer Support Center:\nWebsite: http://www.beckmancoulter.com\nEmail: imunochem@beckman.com",
      "product_quantity": "279 units",
      "distribution_pattern": "Worldwide - U.S. Nationwide distribution in the states of NC and the countries of Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, and  Netherlands.",
      "openfda": {
        "device_name": "Radioimmunoassay, Estrone",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1280",
        "device_class": "1",
        "k_number": [
          "K970915",
          "K864966",
          "K833406",
          "K935013"
        ],
        "registration_number": [
          "1222302",
          "3022178699",
          "2020726",
          "8010132",
          "3002800697",
          "2245285",
          "2133982",
          "3003385757",
          "2029372",
          "3009335633",
          "3007118747",
          "3007361513"
        ],
        "fei_number": [
          "3002806808",
          "1000121039",
          "1000306617",
          "3022178699",
          "2020726",
          "3000717645",
          "3002800697",
          "2245285",
          "3003385757",
          "3009335633",
          "3007118747",
          "3007361513"
        ]
      }
    }
  ]
}