{
  "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": "Princeton",
      "address_1": "400 College Rd E",
      "reason_for_recall": "The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.",
      "address_2": "",
      "product_quantity": "7,057,675 cartridges US ; 772,400 OUS",
      "code_info": "List number 06F15-03, 06F15-04, 03P90-23, 600-9009-25    All lots",
      "center_classification_date": "20120809",
      "distribution_pattern": "Worldwide Distribution - USA including AZ and CO and internationally to  Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Chile, China, Colombia, Costa Rica, Dominican Republic, El Salvador, Finland, France, Georgia,  Germany, Greece, Honduras, Hong Kong, India, Ireland, Italy, Korea, Kuwait, Mauritius, Mexico, Netherland (Antilles), Nigeria, Norway, Oman, Paraguay, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, R.O.C., Thailand, UAE, United Kingdom, and Yemen.",
      "state": "NJ",
      "product_description": "i-Stat cTnl cartridges  Abbott Point of Care Inc.      The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. The cartridge is to be used with the i-Stat Analyzer, but not with the i-Stat Portable Clinical Analyzer or the Philips Medical System (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-Stat System, the cTnl test is to be used by trained health care professionals in accordance with a facility's policies and procedures.",
      "report_date": "20120815",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Abbott Point Of Care Inc.",
      "recall_number": "Z-2169-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "62533",
      "termination_date": "20130208",
      "more_code_info": "",
      "recall_initiation_date": "20120201",
      "postal_code": "08540-6607",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}