{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "121533",
      "product_res_number": "Z-0173-2014",
      "event_date_initiated": "2013-08-16",
      "event_date_posted": "2013-11-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-02-13",
      "res_event_number": "66132",
      "product_code": "CEW",
      "k_numbers": [
        "K020217"
      ],
      "product_description": "ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number:  SMN 10492387\n\nFor in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.",
      "code_info": "Kit Lot: 14136A16 04 Mar 2014",
      "firm_fei_number": "1219913",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc",
      "address_1": "333 Coney St",
      "city": "East Walpole",
      "state": "MA",
      "postal_code": "02032-1516",
      "additional_info_contact": "Erin Hansen\n508-668-5000",
      "reason_for_recall": "PTH Calibrator packaged with only high calibrator.",
      "root_cause_description": "Packaging",
      "action": "Packaging error was brought to Siemens' attention through escalations received from (3) customers in the United States.  Internal Investigation confirmed the issue was limited to the five (5) kits distributed to these customers.  As the customers were aware of the issue and non affected product was provided to the customers to use during Siemens' investigation, no further communication was warranted.",
      "product_quantity": "595 kits total (5 kits with packaging error)",
      "distribution_pattern": "Nationwide Distribution including MD, PA, and CT.",
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        "device_name": "Radioimmunoassay, Parathyroid Hormone",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1545",
        "device_class": "2"
      }
    }
  ]
}