{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Chaska",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "94840",
      "recalling_firm": "Beckman Coulter, Inc.",
      "address_1": "1000 Lake Hazeltine Dr",
      "address_2": "",
      "postal_code": "55318-1037",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of CA, FL, GA, IN, KS, ME, NH, NJ, OK, PA, TX, and WA. The countries of Australia, Austria, Bahrain, Belgium, Brazil, Croatia, Czechia, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Switzerland, Taiwan, and United Kingdom of Great Britain and Northern Ireland.",
      "recall_number": "Z-2735-2024",
      "product_description": "DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.",
      "product_quantity": "183 analyzers",
      "reason_for_recall": "When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when the sample wheel is full, and the LAS continues sending samples despite the limited capacity to process new samples.  Therefore, sample tests may be aliquoted but not processed when the number of tests associated with onboard patient samples exceeds the throughput limit. If this issue occurs test results are flagged with a sample wheel timeout (SWT) error flag, and there may be a delay in reporting test results which could lead to a delay in patient treatment.",
      "recall_initiation_date": "20240522",
      "center_classification_date": "20240827",
      "report_date": "20240904",
      "code_info": "Software versions 1.17.0 or below, UDI-DI 15099590732103.",
      "more_code_info": ""
    }
  ]
}