{
  "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": {
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  "results": [
    {
      "cfres_id": "91335",
      "product_res_number": "Z-0458-2011",
      "event_date_initiated": "2010-04-12",
      "event_date_posted": "2010-11-24",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-03-19",
      "res_event_number": "55604",
      "product_code": "CEC",
      "k_numbers": [
        "K073604"
      ],
      "product_description": "The Dimension FT4L Flex reagent cartridge( Free Thyroxine) manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE.",
      "code_info": "Lot# EC0122 Exp# 05/22/2010, Lot# EG0173, EXP# 06/22/2010, Lot# FA0219, EXP# 08/07/2010, Lot# FA0249, EXP# 09/06/2010, Lot# FB02626, EXP# 09/19/2010.",
      "firm_fei_number": "2517506",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "500 GBC Drive, Mailstop 514 500 GBC Drive Mailstop 514",
      "address_2": "PO BOX 6101",
      "city": "Newark",
      "state": "DE",
      "postal_code": "19714-6101",
      "additional_info_contact": "Technical Solutions\n800-441-9250",
      "reason_for_recall": "Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high elevations, causing the cartridge to leak. Use of leaking cartridges may result in inaccurate test results.",
      "root_cause_description": "Other",
      "action": "Siemens issued an \"Urgent Field Safety Notice\" dated April 2010, informing users of the problem and instructing them to inspect cartridges for leaking fluid. Cartridges with leaking fluid should be reported to the Siemens Technical Solutions Center. The Technical Solutions Center can be contacted at 800 441 9250.",
      "product_quantity": "1520",
      "distribution_pattern": "Worldwide Distribution: USA, Europe, Australia, China, Japan, Korea, and Saudi Arabia.",
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        "device_name": "Radioimmunoassay, Free Thyroxine",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1695",
        "device_class": "2"
      }
    }
  ]
}