{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Tarrytown",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79053",
      "recalling_firm": "Siemens Healthcare Diagnostics",
      "address_1": "511 Benedict Ave",
      "address_2": "N/A",
      "postal_code": "10591-5005",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "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.",
      "recall_number": "Z-0827-2018",
      "product_description": "BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and   BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Test, Thrombin Time      Product Usage:  For in vitro diagnostic use. Reagent for the quantitative determination of the thrombin time in citrated human plasma.",
      "product_quantity": "7631 units",
      "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).",
      "recall_initiation_date": "20171017",
      "center_classification_date": "20180301",
      "termination_date": "20191104",
      "report_date": "20180307",
      "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# Date Manufactured Date Expired  46751                  2016-11-01       2018-09-08  47184                  2017-03-20       2019-02-21"
    }
  ]
}