{
  "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": "94841",
      "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 distribution - US Nationwide distribution in the states of CA, FL, GA, IN, KS, ME, NH, NJ, OK, PA, and TX. The countries of Australia, Austria, Bahrain, Belgium, Brazil, Croatia, Czech Republic, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Switzerland, Taiwan, and United Kingdom.",
      "recall_number": "Z-2544-2024",
      "product_description": "Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.",
      "product_quantity": "183 devices",
      "reason_for_recall": "The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below; and a sample tube is sent from the LAS to DxI 9000 Access Immunoassay Analyzer, an \u001cout of sequence\u001d message will be sent from the Analyzer to the LAS.  This issue may result in multiple error messages (i.e., a sample pick and place (PnP) error or a \u001cno result obtained\u001d (NRT) flag may be displayed) and subsequently a risk of delays in processing/reporting patient test results and patient treatment.",
      "recall_initiation_date": "20240522",
      "center_classification_date": "20240809",
      "report_date": "20240821",
      "code_info": "Software versions 1.17 and below, UDI-DI 15099590732103.",
      "more_code_info": ""
    }
  ]
}