{
  "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": "161249",
      "product_res_number": "Z-0827-2018",
      "event_date_initiated": "2017-10-17",
      "event_date_created": "2018-03-01",
      "recall_status": "Terminated",
      "event_date_terminated": "2019-11-04",
      "res_event_number": "79053",
      "product_code": "GJA",
      "k_numbers": [
        "K970645"
      ],
      "product_description": "BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and \nBC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Test, Thrombin Time\n\n\nProduct Usage:\nFor in vitro diagnostic use. Reagent for the quantitative determination of the thrombin time in citrated human plasma.",
      "code_info": "Manufactured: BC Thrombin Reagent Kit Lot 46751: 3673 kits BC Thrombin Reagent Kit Lot 47184: 3958 kits  Total kits Distributed to Customers Domestic and Foreign:  BC Thrombin Reagent Kit Lot 46751: 3549 kits BC Thrombin Reagent Kit Lot 47184: 2580 kits  Product Code/ Lot#\tDate Manufactured\tDate Expired 46751\t                 2016-11-01\t      2018-09-08 47184\t                 2017-03-20\t      2019-02-21",
      "firm_fei_number": "2432235",
      "recalling_firm": "Siemens Healthcare Diagnostics",
      "address_1": "511 Benedict Ave",
      "city": "Tarrytown",
      "state": "NY",
      "postal_code": "10591-5005",
      "additional_info_contact": "Elizabeth Bernasconi\n914-524-2495",
      "reason_for_recall": "The BC Thrombin Reagent kit lot 46751 (contains Thrombin Reagent lot 517468) and kit lot 47184 (contains Thrombin Reagent lot 517469) produce unexpected prolonged Thrombin Time (TT) results for expected normal samples, and may recover above the upper limit of normal (< 21 sec.) as stated within the IFU (Instruction For Use).",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Siemens sent an Urgent Field Safety Notice letter dated October 2017 to affected customer.\n\nThe letter identified the affected product, problem and actions to be taken by the customer.  Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter and the Urgent Field Corrective Action letter within 30 days.\n\nFor questions contact your Siemens Customers Care Center or local Siemens technical support representative.",
      "product_quantity": "7631 units",
      "distribution_pattern": "Worldwide distribution.  US nationwide, Austria, Belgium, Bosnia-Herzegovina, Croatia, Finland, France (incl. Guadeloupe, Martinique, Reunion, French Guinea overseas departments), Germany, Greece, Hungary, Italy, Kazakhstan, Macedonia, Latvia, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, Spain, Sweden, Turkey, Argentina, Brazil, El Salvador, Mexico, Peru, Uruguay, Canada, and Australia.",
      "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"
        ]
      }
    }
  ]
}