{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Bedford",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91748",
      "recalling_firm": "Instrumentation Laboratory",
      "address_1": "180 Hartwell Rd",
      "address_2": "N/A",
      "postal_code": "01730-2443",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Albania, Algeria,  Australia, Austria, Azerbaijan, Belarus, Belgium, Brazil, Bulgaria, Cape Verde, China,  Colombia, Czech Republic, Egypt, Falkland Islands, Finland, France, Georgia, Germany,  Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Jordan,  Kazakhstan, Kenya, Kossovo, Latvia, Lebanon, Lithuania, Malawi, Malaysia, Mexico,  Philippines, Poland, Romania, Russian Fed., Saudi Arabia, Serbia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom,  Uruguay, Utd.Arab Emir., Vietnam, Zimbabwe.",
      "recall_number": "Z-1305-2023",
      "product_description": "ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing.  Part Number: 0001000311",
      "product_quantity": "129 units US; 2686 units OUS",
      "reason_for_recall": "Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments",
      "recall_initiation_date": "20230203",
      "center_classification_date": "20230330",
      "report_date": "20230405",
      "code_info": "UDI: 08426950451570   Serial Number 23015246 and Prior"
    }
  ]
}