{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "64326",
      "product_res_number": "Z-0580-2008",
      "event_date_initiated": "2007-06-07",
      "event_date_posted": "2008-06-05",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-08-28",
      "res_event_number": "44725",
      "product_code": "MMI",
      "k_numbers": [
        "K053020"
      ],
      "product_description": "ADVIA Centaur TnI-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog # 02790309, and 100 tests - Part/Catalog # 02789602. For in vitro diagnostic use, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591",
      "code_info": "All lots. 500 tests: Part/Catalog #02790309, and 100 tests: Part/Catalog # 02789602.",
      "firm_fei_number": "2432235",
      "recalling_firm": "Siemens Medical Solutions Diagnostics",
      "address_1": "511 Benedict Avenue",
      "city": "Tarrytown",
      "state": "NY",
      "postal_code": "10591-5005",
      "additional_info_contact": "Steven Andberg\n508-359-3825",
      "reason_for_recall": "Incorrect results: Falsely elevated Troponin values have been reported which are inconsistent with the patient's clinical picture and test negative by other Troponin assays.",
      "root_cause_description": "Material/Component Contamination",
      "action": "Two Support Bulletins (078N0361-01 & 078N0361-02) were sent by e-mail to all affected Siemens Diagnostics Branches to inform them of this issue. The first one was sent on 6/07/07 and the second one was sent on 7/05/07. Two Customer Bulletins (078D0647-01 & 078D0651-01) were sent by e-mail to the Siemens Diagnostics Branches for communication with the affected customers. The first one was sent on 6/07/07 and the second one was sent on 7/05/07. These bulletins state that if a false positive is suspected, the sample should be diluted and retested.",
      "product_quantity": "Domestic: 31,497 kits; Foreign: 27,321 kits",
      "distribution_pattern": "Worldwide Distribution - USA, Argentina, Austria, Australia, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Greece, Hong Kong, India, Israel, Italy, Malaysia, Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela",
      "openfda": {
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        "device_name": "Immunoassay Method, Troponin Subunit",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1215",
        "device_class": "2"
      }
    }
  ]
}