{
  "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": "35010",
      "product_res_number": "Z-0053-05",
      "event_date_initiated": "2004-08-20",
      "event_date_posted": "2004-10-28",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-06-09",
      "res_event_number": "30013",
      "product_code": "GJA",
      "k_numbers": [
        "K802117"
      ],
      "product_description": "MDA Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969",
      "code_info": "Product number 252560, Lot number 505046",
      "firm_fei_number": "3002769706",
      "recalling_firm": "bioMerieux",
      "address_1": "100 Rodolphe St Bldg 1300 100 Rodolphe St",
      "address_2": "Bldg 1300",
      "city": "Durham",
      "state": "NC",
      "postal_code": "27712-9402",
      "additional_info_contact": "Jocelyn Jennings\n919-620-2968",
      "reason_for_recall": "Complaints were received from the field regarding prolonged clot times, high control values and erratic results.",
      "root_cause_description": "Other",
      "action": "Consignees were notified by letter on 8/20/2004.",
      "product_quantity": "1165 units",
      "distribution_pattern": "Nationwide, Australia, Brazil, Canada, China, Japan, Laos, Philippines, UK",
      "openfda": {
        "k_number": [
          "K800926",
          "K923220",
          "K900126",
          "K845000",
          "K834301",
          "K811109",
          "K862301",
          "K894467",
          "K884384",
          "K982209",
          "K920147",
          "K781781",
          "K884385",
          "K930157",
          "K822466",
          "K841956",
          "K970645",
          "K802117",
          "K050817",
          "K925493"
        ],
        "device_name": "Test, Thrombin Time",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7875",
        "device_class": "2",
        "registration_number": [
          "2431530",
          "3037000637",
          "1618982",
          "9610806",
          "1835316",
          "9710666",
          "2245451"
        ],
        "fei_number": [
          "2431530",
          "3037000637",
          "3001644026",
          "1618982",
          "3003565434",
          "2245451",
          "3000210416"
        ]
      }
    }
  ]
}