{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Chaska",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91916",
      "recalling_firm": "Beckman Coulter, Inc.",
      "address_1": "1000 Lake Hazeltine Dr",
      "address_2": "N/A",
      "postal_code": "55318-1037",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide, including Puerto Rico and the countries of  Bahrain, Brazil, Canada, China, Costa Rica, El Salvador, Georgia,  Hong Kong, Malaysia, Mexico, Myanmar, New Zealand, Peru, Philippines, Qatar, Singapore, Taiwan, Thailand, Uruguay, and Viet Nam.",
      "recall_number": "Z-1419-2023",
      "product_description": "Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.",
      "product_quantity": "31,076 units",
      "reason_for_recall": "The reagent lot produces elevated results (approximately >30%) in some (15-20%)patient samples that do not correlate with the results of other thyroid markers nor Free T3 results generated on other platforms. This introduces a risk of the positive bias not being detected by QC with the potential that clinical correlation with other thyroid function tests will be inconsistent requiring additional testing; however the clinical assessment and treatment decisions are not made in isolation on a single test result especially, in the setting of thyroid function testing. False positive test results could lead to a euthyroid patient being interpreted clinically as having elevated thyroid function (hyperthyroid) or a hypothyroid patient being within the normal range. Such misdiagnoses may lead to inappropriate treatment of a euthyroid patient with anti-thyroid medications or hypothyroid patient not getting sufficient treatment since their free T3 test result demonstrates them to be in the euthyroid range.",
      "recall_initiation_date": "20230315",
      "center_classification_date": "20230420",
      "report_date": "20230426",
      "code_info": "Lot #233968, exp. 2023-06-30, UDI (01)15099590201661(17)230630(11)220630(10)233968."
    }
  ]
}