{
  "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": "Richmond",
      "address_1": "5205 Route 12",
      "reason_for_recall": "An issue during the manufacturing process caused systems to have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system.",
      "address_2": "",
      "product_quantity": "33 systems",
      "code_info": "Serial #            System  300139           23ADMWS  300157           23ADMWS  300154           23ADMR  300153           23ADMR  300152           23ADMWS  300133           23ADMR  300132          23ADMR  300131          23ASLOMWS  300160          23ADMWS  300127          23AUWS  300128          23ASlDMWS  300151          23ADMR  300150          23ASlDMWS  300155         23ASLDMWS  300159         23ASLOMWS  300129         23ADMR  300156         23ADMWS  300140         23ASLDMWS  300149         23ADMR  300148         23ADMR  300147         23AOMR  300146         23ADMR  300145         23ADMR          300144        23ADMR          300130        23ADMWS   300134        23ASLDMWS  300142         23ASLDMWS  300138         23ASLDMWS  300135         23ADMWS  300136         23ASLDMWS",
      "center_classification_date": "20160610",
      "distribution_pattern": "U.S. consignees: Nationwide; Foreign Consignees: China, Japan, Russia, Italy and England.",
      "state": "IL",
      "product_description": "Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape.     This particular Ariol software application is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed paraffin-embedded tissue specimens immunohistochemically stained for Estrogens Receptors or Progesterone Receptors (ER/PR). ER/PR results are indicated for use as and aid in the management, prognosis, and prediction of therapy outcomes of breast cancer.",
      "report_date": "20160622",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Leica Biosystems Richmond Inc.",
      "recall_number": "Z-1948-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "74178",
      "termination_date": "20171213",
      "more_code_info": "",
      "recall_initiation_date": "20160506",
      "postal_code": "60071",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}