{
  "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": "2026-09-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Brea",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99436",
      "recalling_firm": "Beckman Coulter Inc.",
      "address_1": "250 S Kraemer Blvd",
      "address_2": "",
      "postal_code": "92821-6232",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide.",
      "recall_number": "Z-2973-2026",
      "product_description": "Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower:    1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522;   2) DxC 500 AU Module, DxC 500i, Part Number C63521;   3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical Chemistry Analyzers",
      "product_quantity": "",
      "reason_for_recall": "a software defect in which the Parameter Package (PP)  import logic overwrites all predefined calculated test rules, including those previously  modified by the user, upon import of a new Parameter Package version. As a result, usercustomized  calculated test rules revert silently to their default expressions, potentially  generating erroneous patient test results without an explicit error notification. The issue affects  instruments running software version 1.5 or lower and only occurs when a new Parameter  Package is imported to a system that already has an existing Parameter Package onboard; new  installations are not affected.",
      "recall_initiation_date": "20260715",
      "center_classification_date": "20260817",
      "report_date": "20260826",
      "code_info": "1) Part Number C63522, UDI/DI 14987666545089;  2) Part Number C63521, UDI/DI 14987666545072;  3) Part Number C13252, UDI/DI 15099590742331.",
      "more_code_info": ""
    }
  ]
}