{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Tarrytown",
      "address_1": "511 Benedict Ave",
      "reason_for_recall": "Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater than 5.5 ng/mL with the IMMULITE/IMMULITE 1000 and IMMULITE 2000/IMMULITE 2000 XPi Androstenedione assays (LKAO1, L2KAO2). Siemens has determined that these lots are linear up to a concentration of 5.5 ng/mL, instead of 10 ng/mL as stated in the Instructions for Use (IFU). Quality Control materials at concentrations between 5.5 and 10 ng/mL will detect this issue.",
      "address_2": "",
      "product_quantity": "892",
      "code_info": "Lot Numbers 409 and above",
      "center_classification_date": "20140430",
      "distribution_pattern": "Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, China (People's Republic of), Czech.Rebuplik, Denmark, Estonia, France, Germany, Great Britain, Italy, New Zealand, Portugal, Spain, Switzerland, Turkey and Vatican City.",
      "state": "NY",
      "product_description": "IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SMN 10381158, IVD,  100 test kit size --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK    For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and 2000 Systems Analyzers for the quantitative measurement of 4-androstenedione in human serum.",
      "report_date": "20140507",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Siemens Healthcare Diagnostics",
      "recall_number": "Z-1531-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "67211",
      "termination_date": "20170228",
      "more_code_info": "",
      "recall_initiation_date": "20131220",
      "postal_code": "10591-5005",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}