{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Newark",
      "address_1": "500 GBC Drive, Mailstop 514",
      "reason_for_recall": "Firm has confirmed that if the Cleaner SCS vial becomes empty after processing a test for Antithrombin assay using the INNOVANCE(R) Antithrombin kit, and the test immediately following is an APTT based clotting assay several results may be shortened.",
      "address_2": "PO BOX 6101",
      "product_quantity": "186",
      "code_info": "Device catalog No. OVIO03 (not lot specific)",
      "center_classification_date": "20120625",
      "distribution_pattern": "Worldwide Distribution - US (nationwide) including the states of:  AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IO, KS, KY, LA, MD, MA, MI, MS, MN, MT, NE, NH, NJ, NY, NC, ND, OH, OK, OR, PA, TN, TX, UT, VA, WA, WV, and WI and the countries of:  Australia, France, Canary Islands, Spain, Belgium, Germany, Switzerland, Netherlands, Italy, Guadeloupe, Ceuta, Austria, Slovenia, Croatia, Saudi Arabia, Turkey, Greece, and San Marino.",
      "state": "DE",
      "product_description": "BCS(R) Behring Coagulation System, Device catalog No. OVIO03    Product  Usage:  Multipurpose system for In Vitro coagulation studies",
      "report_date": "20120704",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "recall_number": "Z-1867-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "61768",
      "termination_date": "20140305",
      "more_code_info": "",
      "recall_initiation_date": "20101201",
      "postal_code": "19714-6101",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}