{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "104309",
      "product_res_number": "Z-0180-2012",
      "event_date_initiated": "2011-09-29",
      "event_date_posted": "2011-11-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-03-11",
      "res_event_number": "60048",
      "product_code": "MMI",
      "k_numbers": [
        "K031739"
      ],
      "product_description": "i-Stat cTnI cartridges\n\nIs an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples.",
      "code_info": "List Number 03P90-25; 06F15-03; 06F15-04; 600-9009-25  All lots beginning with letter T.  Various lots.  LOT          List Number\tEXP. DATE T11059\t03P90-25\t28-Sep-11 T11059A\t03P90-25\t28-Sep-11 T11059B\t03P90-25\t28-Sep-11 T11060\t03P90-25\t28-Sep-11 T11060A\t03P90-25\t28-Sep-11 T11060B\t03P90-25\t28-Sep-11 T11061\t03P90-25\t28-Sep-11 T11061A\t03P90-25\t28-Sep-11 T11061C\t03P90-25\t28-Sep-11 T11062A\t03P90-25\t28-Sep-11 T11062B\t03P90-25\t28-Sep-11 T11063\t03P90-25\t28-Sep-11 T11063A\t03P90-25\t28-Sep-11 T11064\t03P90-25\t28-Sep-11 T11065\t03P90-25\t28-Sep-11 T11066\t03P90-25\t28-Sep-11 T11067\t03P90-25\t28-Sep-11 T11068\t06F15-03\t28-Sep-11 T11068A\t03P90-25\t28-Sep-11 T11068B\t03P90-25\t28-Sep-11 T11069\t06F15-03\t28-Sep-11 T11069A\t03P90-25\t28-Sep-11 T11069B\t03P90-25\t28-Sep-11 T11070\t03P90-25\t28-Sep-11 T11070A\t03P90-25\t28-Sep-11 T11070B\t03P90-25\t28-Sep-11 T11070C\t03P90-25\t28-Sep-11 T11070D\t03P90-25\t28-Sep-11 T11072\t03P90-25\t28-Sep-11 T11072A\t03P90-25\t28-Sep-11 T11073\t06F15-03\t28-Sep-11 T11073A\t03P90-25\t28-Sep-11 T11073B\t03P90-25\t28-Sep-11 T11074\t03P90-25\t14-Oct-11 T11074A\t03P90-25\t14-Oct-11 T11075\t03P90-25\t14-Oct-11 T11075A\t03P90-25\t14-Oct-11 T11075B\t03P90-25\t14-Oct-11 T11076\t06F15-03\t14-Oct-11 T11076A\t03P90-25\t14-Oct-11 T11076B\t03P90-25\t14-Oct-11 T11077\t03P90-25\t14-Oct-11 T11077A\t03P90-25\t14-Oct-11 T11078\t03P90-25\t14-Oct-11 T11079\t03P90-25\t14-Oct-11 T11079A\t03P90-25\t14-Oct-11 T11080\t06F15-03\t14-Oct-11 T11081\t03P90-25\t14-Oct-11 T11081A\t03P90-25\t14-Oct-11 T11081B\t06F15-03\t14-Oct-11 T11082\t03P90-25\t14-Oct-11 T11083\t03P90-25\t14-Oct-11 T11083A\t03P90-25\t14-Oct-11 T11083B\t03P90-25\t14-Oct-11 T11084\t03P90-25\t14-Oct-11 T11084A\t03P90-25\t14-Oct-11 T11087\t03P90-25\t14-Oct-11 T11088\t03P90-25\t28-Oct-11 T11088A\t03P90-25\t28-Oct-11 T11089A\t03P90-25\t28-Oct-11 T11089B\t03P90-25\t28-Oct-11 T11090\t03P90-25\t28-Oct-11 T11091\t03P90-25\t28-Oct-11 T11091A\t03P90-25\t28-Oct-11 T11091B\t03P90-25\t28-Oct-11 T11092\t03P90-25\t28-Oct-11 T11095\t03P90-25\t28-Oct-11 T11095A\t03P90-25\t28-Oct-11 T11096\t03P90-25\t28-Oct-11 T11096C\t03P90-25\t28-Oct-11 T11096D\t03P90-25\t28-Oct-11 T11097\t03P90-25\t28-Oct-11 T11097B\t03P90-25\t28-Oct-11 T11098\t03P90-25\t28-Oct-11 T11099\t03P90-25\t28-Oct-11 T11099A\t03P90-25\t28-Oct-11 T11100\t03P90-25\t28-Oct-11 T11101\t03P90-25\t28-Oct-11 T11101A\t03P90-25\t28-Oct-11 T11102\t03P90-25\t28-Oct-11 T11102A\t03P90-25\t28-Oct-11 T11102B\t03P90-25\t28-Oct-11 T11103\t03P90-25\t28-Oct-11 T11103A\t03P90-25\t28-Oct-11 T11104A\t03P90-25\t28-Oct-11 T11104B\t06F15-03\t28-Oct-11 T11105\t06F15-03\t14-Nov-11 T11105A\t06F15-03\t14-Nov-11 T11105B\t06F15-03\t14-Nov-11 T11107\t03P90-25\t14-Nov-11 T11107A\t03P90-25\t14-Nov-11 T11108\t03P90-25\t14-Nov-11 T11108A\t03P90-25\t14-Nov-11 T11108B\t03P90-25\t14-Nov-11 T11109\t06F15-03\t14-Nov-11 T11109B\t06F15-03\t14-Nov-11 T11110\t03P90-25\t14-Nov-11 T11110A\t03P90-25\t14-Nov-11 T11110B\t03P90-25\t14-Nov-11 T11110C\t03P90-25\t14-Nov-11 T11111\t03P90-25\t14-Nov-11 T11111A\t03P90-25\t14-Nov-11 T11112A\t03p90-25\t14-Nov-11 T11112B\t03P90-25\t14-Nov-11 T11113\t03P90-25\t14-Nov-11 T11113A\t03P90-25\t14-Nov-11 T11114\t03P90-25\t14-Nov-11 T11114A\t03p90-25\t14-Nov-11 T11115\t03P90-25\t14-Nov-11 T11115A\t03P90-25\t14-Nov-11 T11116\t03P90-25\t14-Nov-11 T11116A\t06F15-03\t14-Nov-11 T11117\t03P90-25\t14-Nov-11 T11118\t03P90-25\t14-Nov-11 T11118A\t03P90-25\t14-Nov-11 T11118B\t03P90-25\t14-Nov-11 T11118C\t03P90-25\t14-Nov-11 T11119\t03P90-25\t28-Nov-11 T11120\t03P90-25\t28-Nov-11 T11120A\t03P90-25\t28-Nov-11 T11121\t03P90-25\t28-Nov-11 T11121A\t06F15-03\t28-Nov-11 T11122\t06f15-03\t28-Nov-11 T11123\t03P90-25\t28-Nov-11 T11123B\t03P90-25\t28-Nov-11 T11123C\t03P90-25\t28-Nov-11 T11124\t03P90-25\t28-Nov-11 T11124A\t03P90-25\t28-Nov-11 T11124B\t03P90-25\t28-Nov-11 T11125\t03P90-25\t28-Nov-11 T11125A\t03P90-25\t28-Nov-11 T11125C\t03P90-25\t28-Nov-11 T11126\t03P90-25\t28-Nov-11 T11127\t03P90-25\t28-Nov-11 T11127A\t03P90-25\t28-Nov-11 T11128\t03P90-25\t28-Nov-11 T11128B\t03P90-25\t28-Nov-11 T11129A\t03P90-25\t28-Nov-11 T11129B\t03P90-25\t28-Nov-11 T11131A\t03P90-25\t28-Nov-11 T11132\t03P90-25\t28-Nov-11 T11132A\t03P90-25\t28-Nov-11 T11132B\t03P90-25\t28-Nov-11 T11133\t03P90-25\t28-Nov-11 T11136\t03P90-25\t14-Dec-11 T11136A\t03P90-25\t14-Dec-11 T11137\t03P90-25\t14-Dec-11 T11137A\t03P90-25\t14-Dec-11 T11137B\t03P90-25\t14-Dec-11 T11138\t06F15-03\t14-Dec-11 T11138A\t06F15-03\t14-Dec-11 T11138B\t06F15-03\t14-Dec-11 T11139\t03P90-25\t14-Dec-11 T11139A\t03P90-25\t14-Dec-11 T11139B\t03P90-25\t14-Dec-11 T11140\t03P90-25\t14-Dec-11 T11142\t03P90-25\t14-Dec-11 T11143\t03P90-25\t14-Dec-11 T11143A\t03P90-25\t14-Dec-11 T11144\t03P90-25\t14-Dec-11 T11144A\t03P90-25\t14-Dec-11 T11145A\t03P90-25\t14-Dec-11 T11147\t03P90-25\t14-Dec-11 T11147A\t03P90-25\t14-Dec-11 T11149\t03P90-25\t28-Dec-11 T11150\t03P90-25\t28-Dec-11 T11150A\t03P90-25\t28-Dec-11 T11151\t03P90-25\t28-Dec-11 T11151A\t03P90-25\t28-Dec-11 T11151B\t03P90-25\t28-Dec-11 T11153\t03P90-25\t28-Dec-11 T11153A\t03P90-25\t28-Dec-11 T11153B\t03P90-25\t28-Dec-11 T11154\t06F15-03\t28-Dec-11 T11156\t06F15-03\t28-Dec-11 T11156A\t03P90-25\t28-Dec-11 T11157\t03P90-25\t28-Dec-11 T11158\t03P90-25\t28-Dec-11 T11158B\t03P90-25\t28-Dec-11 T11159\t03P90-25\t28-Dec-11 T11160\t03P90-25\t28-Dec-11 T11163A\t03P90-25\t28-Dec-11 T11164\t03P90-25\t28-Dec-11 T11165C\t03P90-25\t28-Dec-11 T11166\t03P90-25\t14-Jan-11 T11167\t06F15-03\t14-Jan-11 T11172\t03P90-25\t14-Jan-11 T11172A\t03P90-25\t14-Jan-11 T11173\t03P90-25\t14-Jan-11 T11174\t03P90-25\t14-Jan-11 T11174B\t03P90-25\t14-Jan-11 T11175\t06F15-03\t14-Jan-11 T11177\t03P90-25\t14-Jan-11 T11186\t03P90-25\t28-Jan-11 T11202\t06F15-03\t28-Jan-11",
      "firm_fei_number": "2245578",
      "recalling_firm": "Abbott Point Of Care Inc.",
      "address_1": "400 College Rd E",
      "city": "Princeton",
      "state": "NJ",
      "postal_code": "08540-6607",
      "additional_info_contact": "Mr. Larry Krasley\n609-454-9292",
      "reason_for_recall": "i-Stat cTnI cartridges beginning with letter \"T\" may exhibit a higher than expected variability in reported results.  This increased variability may result in falsely elevated or falsely depressed results.",
      "root_cause_description": "Material/Component Contamination",
      "action": "APOC issued Urgent Recall Notices/Business Reply Forms dated September 2011 to consignees.  The letter identified the affected product and explained the background of the problem.  Customers are to discontinue use of the cartridges from the lots identified.  All unused product will be credited and should be returned as instructed on the attached Business Reply Card.  If the affected product was further distributed, a copy of the Recall Notice should be provided to those customers as well.  APOC shipped replacement product in order to minimize any disruption.  If replacement product has not been received then customers should contact Customer Service at 1-800-366-8020, option 5.  Questions regarding this information should be directed to Abbott Point of Care Technical Support at 800-366-8020, Option 1 or customers' local APOC representative.",
      "product_quantity": "1,688,755 cartridges",
      "distribution_pattern": "Worldwide Distribution",
      "openfda": {
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        "device_name": "Immunoassay Method, Troponin Subunit",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1215",
        "device_class": "2"
      }
    }
  ]
}