{
  "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": "Newark",
      "state": "DE",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85037",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "500 Gbc Dr",
      "address_2": "N/A",
      "postal_code": "19702-2466",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide  Foreign: Austria, Belgium, Bulgaria, Croatia, Cyprus,  Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom, Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Azerbaijan,  Bahamas, Bahrain, Bangladesh, Benin, Bosnia Herzegovina,  Botswana, Brazil, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Congo, Ecuador, Egypt, French Guinea, Georgia, Guadeloupe, Hong Kong, India, Indonesia, Iraq, Iran, Israel, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Lesotho, Libya, Macedonia, Malawi, Malaysia, Mali, Mexico, Montenegro, Morocco, Mozambique, Myanmar, New Zealand, Nigeria, Oman,  Pakistan, Peru, Philippines, Qatar, Republic if Yemen, Republic Korea, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, South Africa, Swaziland, Taiwan, Tanzania, Thailand, Tunisia, Turkmenistan, United Arab Emirates, Ukraine, Uruguay,  Venezuela, Vietnam, Zimbabwe",
      "recall_number": "Z-1537-2020",
      "product_description": "Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin   SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates using the Atellica¿ CH Analyzer. Measurement of total bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder block, A total bilirubin measurement in newborn infants is intended to aid in indicating the risk of bilirubin encephalopathy (kernicterus).",
      "product_quantity": "2323 US and 8193 OUS",
      "reason_for_recall": "Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy",
      "recall_initiation_date": "20200213",
      "center_classification_date": "20200320",
      "termination_date": "20210423",
      "report_date": "20200401",
      "code_info": "Lot # UDI Number  190028 (01)00630414595818(10)190028(17)20200420                                         190063 (01)00630414595818(10)190063(17)20200601                                         190112 (01)00630414595818(10)190112(17)20200810                                         190152 (01)00630414595818(10)190152(17)20201005                                         190205 (01)00630414595818(10)190205(17)20201221                                         190235 (01)00630414595818(10)190235(17)20210118                                         190265 (01)00630414595818(10)190265(17)20210301",
      "more_code_info": ""
    }
  ]
}