{
  "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": "32282",
      "product_res_number": "Z-0782-04",
      "event_date_initiated": "2004-03-26",
      "event_date_posted": "2004-07-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-10-14",
      "res_event_number": "28649",
      "product_code": "MMI",
      "k_numbers": [
        "K974103"
      ],
      "product_description": "AxSYM Troponin-I Reagent Kit, list 3C29-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064",
      "code_info": "lot numbers 10264M300, 10264M301, 10265M300, and 10265M301",
      "firm_fei_number": "1415939",
      "recalling_firm": "Abbott Laboratories HPD/ADD/GPRD",
      "address_1": "100/200 Abbott Park Road",
      "city": "Abbott Park",
      "state": "IL",
      "postal_code": "60064",
      "additional_info_contact": "Abbott Customer Support \n877-422-2688",
      "reason_for_recall": "An increase in complaints of higher than normal patient results, some from the healthy population range to above the diagnostic cutoff for an Acute Myocardial Infarction.",
      "root_cause_description": "Other",
      "action": "Recalled by telephone calls on 3/26/04 and a follow-up letter dated 3/25/04. The accounts were informed of the elevated patient results for the Troponin-I Reagent lots, and were requested to discontinue use and destroy any of the four affected lots found in inventory.",
      "product_quantity": "7,394 kits",
      "distribution_pattern": "Nationwide and internationally to Abbott affiliates in Argentina, Canada, Germany, Singapore, Hong Kong, \nTaiwan, Australia, New Zealand, Thailand, China and Korea.",
      "openfda": {
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        "device_name": "Immunoassay Method, Troponin Subunit",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1215",
        "device_class": "2"
      }
    }
  ]
}