{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Tarrytown",
      "address_1": "511 Benedict Ave",
      "reason_for_recall": "Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number of euthyroid patients (those with normal function of the thyroid) demonstrating values above the recommended normal range as published in the Instructions For Use for the IMMULITE/IMMULITE 1000 and/or IMMULITE 2000/IMMULITE 2000 XPi for several lots of Free T3 kits.  A positive bias in quality control results was also observed, but the values may remain within the established ranges.",
      "address_2": "",
      "product_quantity": "4695 kits in total",
      "code_info": "Lot Numbers 737, 738, 739, 740, 741, 742, 743",
      "center_classification_date": "20140130",
      "distribution_pattern": "Worldwide Distribution-USA (nationwide) and the countries of  Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Bosnia-Herzegovina, Brazil, Belarus, Canary Islands, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Great Britain, Greece, Guatemala, Honduras, Hungary, Iceland, India, Indonesia, Ireland, Israel, Iran, Italy, Jordan, Republic of South Korea, Kuwait, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Mexico, Malaysia, Malta, Nepal, Netherlands, Norway, Panama, Peru, Philippines, Pakistan, Paraguay, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sri Lanka, South Africa, Switzerland, Turkey, Thailand, Taiwan, Uruguay, Usbekistan, Venezuela, Vietnam, and United Arab Emirates.",
      "state": "NY",
      "product_description": "T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) 10381675, and REF/Catalog Number L2KF36 (600 Tests), SMN 10381682; an IVD Immunoassay kit for use with the IMMULITE 2000/IMMULITE 200 XPi Analyzers --- Origin: UK  Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL UK.    For the quantitative measurement of Free T3 in serum, as an aid in the clinical assessment of thyroid status.",
      "report_date": "20140205",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Siemens Healthcare Diagnostics",
      "recall_number": "Z-0868-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "66055",
      "termination_date": "20170228",
      "more_code_info": "",
      "recall_initiation_date": "20130827",
      "postal_code": "10591-5005",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}