{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "115267",
      "product_res_number": "Z-0716-2013",
      "event_date_initiated": "2012-11-01",
      "event_date_posted": "2013-01-24",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-06-14",
      "res_event_number": "64043",
      "product_code": "MMI",
      "k_numbers": [
        "K031739"
      ],
      "product_description": "Abbott Point of Care i-Stat cTnI cartridge.\n\nThe i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to the relative risk of mortality.",
      "code_info": "List number 06F15-03, O6F15-04, 03P90-25, 600-9009-25 Lot number P12179",
      "firm_fei_number": "3005643513",
      "recalling_firm": "Abbott Point of Care Canada Limited",
      "address_1": "185 Corkstown Road",
      "city": "Nepean",
      "country": "Canada",
      "additional_info_contact": "Mr. Joseph Kiciena\n609-454-9494",
      "reason_for_recall": "APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack.",
      "root_cause_description": "Error in labeling",
      "action": "APOC sent an \"IMPORTANT PRODUCT INFORMATION\" letter dated October 2012 to all affected customers.  The letter identified the product, problem, and actions to be taken by the customers.  Contact Abbott Point Of Care Technical Support at 800-366-8020, Option 1 or your Abbott Point Of Care representative for questions regarding this information.",
      "product_quantity": "560 boxes (25 cartridges in each box)",
      "distribution_pattern": "Worldwide Distribution.",
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        "device_name": "Immunoassay Method, Troponin Subunit",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1215",
        "device_class": "2"
      }
    }
  ]
}