{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "East Walpole",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79678",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc",
      "address_1": "333 Coney St",
      "address_2": "N/A",
      "postal_code": "02032-1516",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide, and the following countries: Albania, Angola, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Mexico, Morocco, Myamar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan,Thailand, Turkey, United Arab Emirates, Ukraine, United Kingdom, Uruguay, Uzbekistan,Vatican City, and Vietnam.",
      "recall_number": "Z-1486-2018",
      "product_description": "ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)",
      "product_quantity": "SMN 10310443 (1-pack/100 tests) - 13257 kits;  SMN 10315696 (5-pack/500 tests) - 9930 kits",
      "reason_for_recall": "Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.",
      "recall_initiation_date": "20180221",
      "center_classification_date": "20180424",
      "termination_date": "20190516",
      "report_date": "20180502",
      "code_info": "SMN 10310443 (1-pack/100 tests):  Lot 71804174, Exp 2018-Apr-27, UDI (01)00630414461298(10)71804174(17)20180427  Lot 73838174, Exp 2018-Apr-27, UDI (01)00630414461298(10)73838174(17)20180427  Lot 88601174, Exp 2018-Apr-27, UDI (01)00630414461298(10)88601174(17)20180427  Lot 94549174, Exp 2018-Apr-27, UDI (01)00630414461298(10)94549174(17)20180427  Lot 23904176, Exp 2018-Aug-30, UDI (01)00630414461298(10)23904176(17)20180830  Lot 24439176, Exp 2018-Aug-30, UDI (01)00630414461298(10)24439176(17)20180830  Lot 31842176, Exp 2018-Aug-30, UDI (01)00630414461298(10)31842176(17)20180830  Lot 42051176, Exp 2018-Aug-30, UDI (01)00630414461298(10)42051176(17)20180830  Lot 54008176, Exp 2018-Aug-30, UDI (01)00630414461298(10)54008176(17)20180830    SMN 10315696 (5-pack/500 tests):  Lot 71229174, Exp 2018-Apr-27, UDI (01)00630414461304(10)71229174(17)20180427  Lot 73455174, Exp 2018-Apr-27, UDI (01)00630414461304(10)73455174(17)20180427  Lot 84113174, Exp 2018-Apr-27, UDI (01)00630414461304(10)84113174(17)20180427  Lot 91568174, Exp 2018-Apr-27, UDI (01)00630414461304(10)91568174(17)20180427  Lot 23903176, Exp 2018-Aug-30, UDI (01)00630414461304(10)23903176(17)20180830  Lot 24944176, Exp 2018-Aug-30, UDI (01)00630414461304(10)24944176(17)20180830  Lot 41442176, Exp 2018-Aug-30, UDI (01)00630414461304(10)41442176(17)20180830  Lot 46735176, Exp 2018-Aug-30, UDI (01)00630414461304(10)46735176(17)20180830"
    }
  ]
}