{
  "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,
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  "results": [
    {
      "cfres_id": "36108",
      "product_res_number": "Z-0383-05",
      "event_date_initiated": "2004-12-03",
      "event_date_posted": "2005-01-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-09-08",
      "res_event_number": "30563",
      "k_numbers": [
        "K000784"
      ],
      "product_description": "Roche brand Cardiac Reader.",
      "code_info": "All units.",
      "firm_fei_number": "1823260",
      "recalling_firm": "Roche Diagnostics Corp.",
      "address_1": "9115 Hague Rd",
      "city": "Indianapolis",
      "state": "IN",
      "postal_code": "46256-1025",
      "additional_info_contact": "800-428-2336",
      "reason_for_recall": "Potential for false negative Troponin T or falsely decreased Troponin T and Myoglobin results.",
      "root_cause_description": "Other",
      "action": "User hospitals were notified via phone, letter and fax (beginning on 12/3/04) a copy of the recall notification on December 3, 2004, which instructed them to immediately cease using the device.  The firm issued a press release on December 8, 2004.",
      "product_quantity": "95",
      "distribution_pattern": "United States.",
      "openfda": {}
    }
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}