{
  "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": [
    {
      "status": "Terminated",
      "city": "Edison",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "64076",
      "recalling_firm": "International Technidyne Corp.",
      "address_1": "68 Olsen Ave",
      "address_2": "N/A",
      "postal_code": "08820-2419",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Internationally to Bermuda, Canada, Chile, Denmark, Germany, Italy, Latvia, Lithuania, Malaysia, Philippines, South Africa, Spain, Switzerland, Taiwan, and United Arab Emirates.",
      "recall_number": "Z-0837-2013",
      "product_description": "Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50.  International Technidyne Corporation.     The Pro Time Microcoagulation System is a portable battery operated instrument with a disposable cuvette for quantitative determination of prothrombin time from fingerstick whole blood or anticoagulant free venous whole blood.",
      "product_quantity": "11,742 boxes US (25 cuvettes per box); 22,968 boxes OUS (25 cuvettes per box)",
      "reason_for_recall": "Some Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothrombin Time/International Normalized Ratio (PT/INR) results.",
      "recall_initiation_date": "20120928",
      "center_classification_date": "20130219",
      "termination_date": "20140109",
      "report_date": "20130227",
      "code_info": "Pro3-25      A2K3C001 1/31/2013  A2K3C002 1/31/2013  A2P3C003 1/31/2013  A2P3C004 1/31/2013  A2K3C005 1/31/2013  A2K3C006 1/31/2013  A2K3C007 1/31/2013  A2K3C008 1/31/2013  A2K3C009 1/31/2013  A2K3C011 1/31/2013  A2K3C013 1/31/2013  A2K3C015 1/31/2013  A2K3C016 1/31/2013  A2K3C017 1/31/2013  A2K3C018 1/31/2013  A2K3C019 1/31/2013  A2K3C020 1/31/2013  A2K3C021 1/31/2013  A2K3C022 1/31/2013  A2K3C023 1/31/2013  A2K3C0241/31/2013  A2K3C025 1/31/2013  A2K3C026 1/31/2013  A2K3C027 1/31/2013  B2K3C028 2/28/2013    B2K3C030 2/28/2013  B2K3C031 2/28/2013  B2K3C032 2/28/2013  B2K3C033 2/28/2013  B2K3C034 2/28/2013  B2K3C035 2/28/2013  B2K3C036 2/28/2013  B2K3C037 2/28/2013  B2K3C038 2/28/2013  B2K3C039 2/28/2013  B2K3C040 2/28/2013  B2K3C041 2/28/2013  B2K3C042 2/28/2013  B2K3C043 2/28/2013  B2K3C044 2/28/2013  B2K3C045 2/28/2013  B2K3C046 2/28/2013  C2K3C048 3/31/2013  C2K3C049 3/31/2013  C2K3C050 3/31/2013  C2K3C051 3/31/2013  C2K3C052 3/31/2013  C2K3C053 3/31/2013  C2K3C054 3/31/2013  C2K3C055 3/31/2013  C2K3C056 3/31/2013  C2K3C058 3/31/2013  C2K3C059 3/31/2013  C2K3C061 3/31/2013  D2K3C078 4/30/2013  M1K3C474 12/31/2012  M1K3C475 12/31/2012  M1K3C476 12/31/2012  M1K3C477 12/31/2012  M1P3C478 12/31/2012  M1P3C479 12/31/2012  M1P3C480 12/31/2012  M1P3C481 12/31/2012  M1P3C482 12/31/2012      PRO3-4   A2K3H015 1/31/2013  B2K3H029 2/28/2013  B2K3H033 2/28/2013  B2K3H047 2/28/2013  C2K3H049 3/31/2013  C2K3H055 3/31/2013  C2K3H057 3/31/2013    PRO3-50   B2P3C029 2/28/2013  B2P3C030 2/28/2013  B2P3C033 2/28/2013  C2P3C057 3/31/2013"
    }
  ]
}