{
  "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": "2026-04-15",
    "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": "75487",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "511 Benedict Ave",
      "address_2": "N/A",
      "postal_code": "10591-5005",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US (Nationwide) Internationally to Canada, Mexico, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Chile, Cyprus, Denmark, Egypt, Ecuador, Finland, France, Germany, Great Britain, Hong Kong, Hungary, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Poland, Portugal, Russian Fed. Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, Vatican City and Vietnam",
      "recall_number": "Z-0589-2017",
      "product_description": "Advia Chemistry Calibrator   For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct Bilirubin (DBIL_2), Total Bilirubin (TBIL_2), Calcium (CA, CA_c, CA_2, CA_2c), Cholesterol (CHOL), Creatinine (CREA, CREA_2, CRE_2c, ECRE_2), Glucose Hexakinase (GLUH), Glucose Oxidase (GLUO), Iron (IRON_2), Lithium (LITH), Magnesium (MG, MG_c), Phosphorus - inorganic (IP, IP_c), Total Protein (TP, TP_c), Triglycerides (TRIG), Urea Nitrogen (UN, UN_c), Uric Acid (UA, UA_c)",
      "product_quantity": "10,614 units",
      "reason_for_recall": "Siemens has confirmed that the DBIL_2 Assigned Calibrator Values (ACV) currently assigned to the affected lots may cause, on average, a positive proportional bias of approximately 41% on patient samples compared to the reference method for Direct Bilirubin measurement.",
      "recall_initiation_date": "20161007",
      "center_classification_date": "20161116",
      "termination_date": "20180510",
      "report_date": "20161123",
      "code_info": "Device Listing # D033650  Model# SMN# 10312279  Lot Numbers: 680726, 680726A, 680726B, 680726C, 680726D"
    }
  ]
}