{
  "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": "2026-05-06",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Carlsbad",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63368",
      "recalling_firm": "Sendx Medical Inc",
      "address_1": "1945 Palomar Oaks Way",
      "address_2": "N/A",
      "postal_code": "92011-1300",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution-- US Distribution including the state of Ohio and the countries of Switzerland, Germany, France, Poland, Austria, Italy, Japan, Australia, Denmark, China, Sweden, Norway, Spain, United Kingdom, Netherlands, and Czech Republic.",
      "recall_number": "Z-0195-2013",
      "product_description": "ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35).    The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point of care setting",
      "product_quantity": "767 units",
      "reason_for_recall": "The recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80 FLEX CO-OX analyzer related to the reporting of the hemoglobin fractional parameters.",
      "recall_initiation_date": "20100106",
      "center_classification_date": "20121105",
      "termination_date": "20121105",
      "report_date": "20121114",
      "code_info": "Serial Numbers:  all ABL80 FLEX CO-OX analyzers with sofware versions 1.30, 1.31, 1.32, 1.33, and 1.34."
    }
  ]
}