{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Tarrytown",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "84947",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "511 Benedict Ave",
      "address_2": "",
      "postal_code": "10591-5005",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, KY, LA, MA, MD, MI, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI. SC, TN, TX, UT, VA, WA, WI, WY, and countries of AE, AF, AL, AO, AR, AT, AU, AZ, BD, BE, BO, BG, BH, BR, CA, CH, CO, CL, CN, CO, CR, CY, DE, DO, DZ, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, IE, IN, IR, IS, IT, IQ, JO, KE, KR, LB, LT, LV, LY, ME, MK, MX, NL, NO, PA, PE, PH, PK, PL, PS, PT, PY, QA, RO, RU, SA, SE, SK, SL, SV, SY, TH, TJ, TM, TN, TR, TW, UA, UY, UZ, VE, VN, XK, XS, ZA",
      "recall_number": "Z-1513-2020",
      "product_description": "IMMULITE 1000 Systems E2 Estradiol  Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers  for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual disorders.",
      "product_quantity": "2267 kits",
      "reason_for_recall": "Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as pre-menopausal when truly post- menopausal. This may lead to delayed initiation of a potentially beneficial drug and/or administration of an unnecessary drug in the treatment for hormone receptor positive advanced or metastatic breast cancer.",
      "recall_initiation_date": "20200205",
      "center_classification_date": "20200318",
      "termination_date": "20211118",
      "report_date": "20200325",
      "code_info": "Lot #: All in date kit lots beginning 501 and above.   Code: Siemens Material Number (SMN) & (UDI) for US:  10702832 (00630414947891); SMN & (UDI) for OUS: 10381132 (00630414966151)",
      "more_code_info": ""
    }
  ]
}