{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 6
    }
  },
  "results": [
    {
      "cfres_id": "192971",
      "product_res_number": "Z-1020-2022",
      "event_date_initiated": "2022-03-03",
      "event_date_created": "2022-04-29",
      "recall_status": "Open, Classified",
      "res_event_number": "89953",
      "product_code": "CHP",
      "product_description": "Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots",
      "code_info": "All lot numbers\nUDI:\n(01)00630414598857(10)53376082(17)20220521\n(01)00630414598857(10)53377082(17)20220521\n(01)00630414598857(10)70533084(17)20220804",
      "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": "SAME\n508-668-5000",
      "reason_for_recall": "Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results",
      "root_cause_description": "Under Investigation by firm",
      "action": "Siemens issued an Urgent Medical Device Correction AIMC 22-03.A.US and Urgent\nField Safety Notice AIMC 22-03.A.OUS on 3/3/22. Letter states reason, health risk and action to take:\nCustomers must discontinue use of plasma specimens for testing with the Atellica IM and\nADVIA Centaur eE2 assays until further notice.\nCustomers may continue to use the Atellica IM eE2 and ADVIA Centaur eE2 assays with\nserum specimens.\nPlease review this letter with your Medical Director.\nComplete and return the Field Correction Effectiveness Check Form attached to this letter\nwithin 30 days.\nIf you have received any complaints of illness or adverse events associated with the\nproducts listed in Table 1, immediately contact your local Siemens Healthineers Customer\nCare Center or your local Siemens Healthineers technical support representative.\nPlease retain this letter with your laboratory records and forward this letter to those who may have received this product.\n\nQuestions: contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative",
      "product_quantity": "2,044 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Bulgaria, Burkina, Faso Country AG, Cyprus, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Greece, Guadeloupe, India, Ireland, Israel, Italy, Kazakhstan, Latvia, Lithuania, Macedonia, Malta, Morocco, Nepal, Netherlands, Norway, Palestinian Ter, Paraguay, Poland, Portugal, Qatar, Romania, Russian Fed., Slovakia, Spain, Sweden, Switzerland, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Vatican city.",
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        "device_name": "Radioimmunoassay, Estradiol",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1260",
        "device_class": "1"
      }
    }
  ]
}