{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "131165",
      "product_res_number": "Z-0467-2015",
      "event_date_initiated": "2014-09-18",
      "event_date_posted": "2014-12-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-03-28",
      "res_event_number": "69621",
      "product_code": "JKR",
      "k_numbers": [
        "K982491"
      ],
      "product_description": "Calcitonin ELISA Kit, Code No. 7024, 7024BU.\n\nIntended use of this product is the quantitative determination of Calcitonin in human serum.",
      "code_info": "Lot No. 2041, 2071, 2089, 2124, 2167, 2178, 2180.",
      "firm_fei_number": "3007981058",
      "recalling_firm": "Biomerica",
      "address_1": "17571 Von Karman Ave",
      "city": "Irvine",
      "state": "CA",
      "postal_code": "92614-6207",
      "additional_info_contact": "949-645-2111",
      "reason_for_recall": "A potential issue with false high values.",
      "root_cause_description": "Material/Component Contamination",
      "action": "An Urgent Field Safety Notice dated 9/18/14 was sent to all their customers who purchased the Calcitonin ELISA Kit.  The letter informed the customers of the problems identified and the actions to be taken.  Customers were to examine their inventory immediately and quarantine any affected product.  Also, customers were asked to notify any customers that the product was further distributed to.  Customers with questions were instructed to contact their local Customer Service or Sales Representative regarding the recall notification.  Customers were instructed to complete and return the enclosed response form by either fax or email as soon as possible and not later than 10/1/14.",
      "product_quantity": "1,062 units",
      "distribution_pattern": "Worldwide Distribution -- USA, including the states of NH, CA, NJ, FL; and, the countries of Russia, Ukraine, Switzerland, Spain, Italy, Serbia, China, France, Pakistan, Austria, United Kingdom, Egypt, and India.",
      "openfda": {
        "k_number": [
          "K990073",
          "K982491",
          "K912536",
          "K854240",
          "K945961",
          "K132828",
          "K821675",
          "K182012",
          "K961043",
          "K872880",
          "K252431",
          "K874087",
          "K861274",
          "K842907",
          "K781909",
          "K023304",
          "K951708",
          "K964635",
          "K914429",
          "K060578"
        ],
        "registration_number": [
          "2432235",
          "2182595",
          "3002800697",
          "2245285",
          "8032314",
          "2032839",
          "2020726",
          "9610126",
          "1222302",
          "2025099",
          "3002806944"
        ],
        "fei_number": [
          "2432235",
          "2182595",
          "3002806559",
          "3002800697",
          "2245285",
          "2020726",
          "3007981058",
          "3004185580",
          "1000121039",
          "3002808140",
          "3002806944"
        ],
        "device_name": "Radioimmunoassay, Calcitonin",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1140",
        "device_class": "2"
      }
    }
  ]
}