{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
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  "results": [
    {
      "cfres_id": "37505",
      "product_res_number": "Z-0576-05",
      "event_date_initiated": "2005-02-23",
      "event_date_posted": "2005-03-08",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-09-02",
      "res_event_number": "31253",
      "product_code": "KXT",
      "k_numbers": [
        "K925802"
      ],
      "product_description": "Access Immunoasay Systems Digoxin Reagent",
      "code_info": "Lots 323171; 416110; 417703; 419534",
      "firm_fei_number": "2050012",
      "recalling_firm": "Beckman Coulter Inc",
      "address_1": "200 S Kraemer Blvd",
      "city": "Brea",
      "state": "CA",
      "postal_code": "92822-6208",
      "additional_info_contact": "Kathleen Jaker\n714-961-4123",
      "reason_for_recall": "Variability in results on Patient and QC results of 20-25%, high and low.",
      "root_cause_description": "Other",
      "action": "Letters were sent to customers via UPS overnite, they request that alternative methods be used for patient testing until new material is made available. Customers are requested to ask for replacements using a fax back form.",
      "product_quantity": "4352 domestically.",
      "distribution_pattern": "Nationwide and Canada",
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        "device_name": "Enzyme Immunoassay, Digoxin",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3320",
        "device_class": "2"
      }
    }
  ]
}