{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "66757",
      "recalling_firm": "Abbott Point Of Care Inc.",
      "address_1": "400 College Rd E",
      "address_2": "N/A",
      "postal_code": "08540-6607",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Brazil, Chile, China, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, South Korea, Kuwait, Mexico, Netherland, New Zealand, Nigeria, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, south Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE, and United Kingdom,",
      "recall_number": "Z-0451-2014",
      "product_description": "Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540    The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the PT/INR test is to be used by trained health care professionals in accordance with a facility's policies and procedures.",
      "product_quantity": "794,928 units US; 119,472 units OUS",
      "reason_for_recall": "Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential to exhibit incorrectly elevated INR.",
      "recall_initiation_date": "20131028",
      "center_classification_date": "20131204",
      "termination_date": "20140529",
      "report_date": "20131211",
      "code_info": "K020355    List number 04J50-01, 04J50-02; 03P89-24    Lot number R13149A; R13151; R13151A and cartridge lots from C13139 up to and including C13270A"
    }
  ]
}