{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Lincolnshire",
      "address_1": "577 Aptakisic Rd",
      "reason_for_recall": "Reported customer complaints of automated hematology analyzers catching fire due to misalignment of an internal protective sheet that shields electronic components from salty reagents.  Build-up of salt deposits on  unprotected electronic components may combust due to heat generated by electronics when instrument cycles. Completed CAPA identified the root cause as supplier providing defective component (sensor ready valve) and the misalignment of the electronic protective shield during manufacturing of the device.",
      "address_2": "",
      "product_quantity": "3,682 units",
      "code_info": "**Model: XN-10, Product Number: AP795756, Serial Numbers: 11001 \u0013 29656, 29668-29786, 29788-29798, 29800-29801, 29803, 29804, 29807, 29812, 29816-29867    **Model: XN-11, Product Number: CS297931, Serial Numbers: A1001-A1124, A1127, A1130, A1135-A1140, A1142-A1144, A1146-A1149, A1151, A1153-A1159, A1161, A1163, A1171",
      "center_classification_date": "20170504",
      "distribution_pattern": "Nationwide, Canada",
      "state": "IL",
      "product_description": "Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan",
      "report_date": "20170510",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Sysmex America Inc",
      "recall_number": "Z-2034-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "76828",
      "termination_date": "20190822",
      "more_code_info": "",
      "recall_initiation_date": "20170323",
      "postal_code": "60069-4325",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}