{
  "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": [
    {
      "status": "Terminated",
      "city": "Kobe-shi",
      "state": "",
      "country": "Japan",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "70054",
      "recalling_firm": "Sysmex Corporation",
      "address_1": "1 5 1 Wakinohamakaigandoori",
      "address_2": "CHUO-KU",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY + District of Columbia + Guam; Internationally to Australia, Bahrain, Bangladesh, Cambodia, Canada, China, Germany, Hong Kong, India, Indonesia, Malaysia, Maldives, Mongolia, Mynamar, Nepal, New Zealand, Pakistan, Philippines, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, and Vietnam.    THE CORRECTION IS LIMITED TO XN-10/XN-20 UNITS DISTRIBUTED BY SYSMEX AMERICA, INC., INSTALLED AT END-USER SITES IN US, PUERTO RICO, AND CANADA.",
      "recall_number": "Z-1945-2016",
      "product_description": "The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.",
      "product_quantity": "1,137 units (US) 54 units (Canada) 9 inventory",
      "reason_for_recall": "There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.",
      "recall_initiation_date": "20141218",
      "center_classification_date": "20160610",
      "termination_date": "20160725",
      "report_date": "20160622",
      "code_info": "1) Model: XN-10; Catalog Number: AP795756; Serial Numbers: 111001-15483 except 15287, 15298, 15308, 15408, 15442, 15454, 15470 and 15484;     2) Model: XN-20; Catalog Number: AE797961; Serial Numbers: 11001-12118 except 11960, 12039, 12078, 12114, and 12117.",
      "more_code_info": ""
    }
  ]
}