{
  "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-1538-2020",
      "product_description": "ADVIA Chemistry Direct Bilirubin_2 assay-SMN:  10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice.    In vitro Diagnostic for the determination of direct bilirubin.",
      "product_quantity": "1901 Us and 37349  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": "ADVIA CH DBIL_2 (20 mL) 492068 (01)00630414513089(10)492068(17)20210728                 ADVIA CH DBIL_2 (20 mL) 486501 (01)00630414513089(10)486501(17)20210628                                         ADVIA CH DBIL_2 (20 mL) 478164 (01)00630414513089(10)478164(17)20210328                                         ADVIA CH DBIL_2 (20 mL) 472667 (01)00630414513089(10)472667(17)20210228                                         ADVIA CH DBIL_2 (20 mL) 469068 (01)00630414513089(10)469068(17)20201228                                         ADVIA CH DBIL_2 (20 mL) 462448 (01)00630414513089(10)462448(17)20201028                                         ADVIA CH DBIL_2 (20 mL) 455476 (01)00630414513089(10)455476(17)20200728                                         ADVIA CH DBIL_2 (20 mL) 452841 (01)00630414513089(10)452841(17)20200628                                         ADVIA CH DBIL_2 (20 mL) 447337 (01)00630414513089(10)447337(17)20200528                                         ADVIA CH DBIL_2 (20 mL) 436518 (01)00630414513089(10)436518(17)20200228                                          ADVIA CH DBIL_2 (70 mL) 486509 (01)00630414513065(10)486509(17)20210628        ADVIA CH DBIL_2 (70 mL) 478169 (01)00630414513065(10)478169(17)20210328                                         ADVIA CH DBIL_2 (70 mL) 472672 (01)00630414513065(10)472672(17)20210228                                         ADVIA CH DBIL_2 (70 mL) 469073 (01)00630414513065(10)469073(17)20201228                                         ADVIA CH DBIL_2 (70 mL) 462453 (01)00630414513065(10)462453(17)20201028                                         ADVIA CH DBIL_2 (70 mL) 462459 (01)00630414513065(10)462459(17)20201028           ADVIA CH DBIL_2 (70 mL) 455481 (01)00630414513065(10)455481(17)20200728                                         ADVIA CH DBIL_2 (70 mL) 452846 (01)00630414513065(10)452846(17)20200628                                         ADVIA CH DBIL_2 (70 mL) 447351 (01)00630414513065(10)447351(17)20200528                                         ADVIA CH DBIL_2 (70 mL) 447357 (01)00630414513065(10)447357(17)20200528       ADVIA CH DBIL_2 (70 mL) 458975 (01)00630414513065(10)458975(17)20200528                                         ADVIA CH DBIL_2 (70 mL) 436523 (01)00630414513065(10)436523(17)20200228",
      "more_code_info": ""
    }
  ]
}