{
  "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": 28
    }
  },
  "results": [
    {
      "cfres_id": "34917",
      "product_res_number": "Z-0007-05",
      "event_date_initiated": "2004-07-21",
      "event_date_posted": "2004-10-05",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-12-15",
      "res_event_number": "29987",
      "product_code": "GJA",
      "k_numbers": [
        "K970645"
      ],
      "product_description": "BC Thrombin Reagent . Thrombin Time Test",
      "code_info": "Lot 540624, Lot 540625, and Lot 540626",
      "firm_fei_number": "2517506",
      "recalling_firm": "Dade Behring , Inc.",
      "address_1": "Rte 896, Glasgow Business Community Rte 896 Glasgow Business Community",
      "city": "Newark",
      "state": "DE",
      "postal_code": "19702",
      "additional_info_contact": "Donna A. Wolf\n302-631-0384",
      "reason_for_recall": "The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients recieving heparin",
      "root_cause_description": "Other",
      "action": "The recalling firm issued a recall letter dated 7/21/04 to their accounts informing them of the problem and the need to discard the product.",
      "product_quantity": "3942 kits",
      "distribution_pattern": "The products were shipped to medical facilities in CT, FL, IA, IL, NJ, PA, and WI. The products were also shipped to Austria, Bosnia, Croatia, Hungry, Germany, Poland, Spain, RussiaFrance, Italy, Australia, Brazil, Canada, Saudi Arabia, El Salvador, and Turkey.",
      "openfda": {
        "k_number": [
          "K845000",
          "K841956",
          "K982209",
          "K894467",
          "K834301",
          "K930157",
          "K970645",
          "K884385",
          "K781781",
          "K923220",
          "K800926",
          "K802117",
          "K050817",
          "K900126",
          "K811109",
          "K920147",
          "K925493",
          "K884384",
          "K862301",
          "K822466"
        ],
        "device_name": "Test, Thrombin Time",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7875",
        "device_class": "2",
        "registration_number": [
          "9610806",
          "9710666",
          "2431530",
          "3037000637",
          "1835316",
          "2245451",
          "1618982"
        ],
        "fei_number": [
          "2431530",
          "3037000637",
          "3003565434",
          "3000210416",
          "2245451",
          "3001644026",
          "1618982"
        ]
      }
    }
  ]
}