{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "150705",
      "product_res_number": "Z-0612-2017",
      "event_date_initiated": "2016-10-19",
      "event_date_created": "2016-11-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-03-02",
      "res_event_number": "75523",
      "product_code": "NIG",
      "k_numbers": [
        "K031393"
      ],
      "product_description": "ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with  the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems.\nSiemens Material Number(SMN): 10491379\n\nIn the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT instrument. Siemens stated that  the assay is being marketed on the XPT following FDAs Reagent Replacement Policy.  Siemens plans to request  CLIA Categorization for the CA19-9 assay on XPT the week of 11/21/2016.",
      "code_info": "Kit lots ending in: 380                 Exp Date        2016-10-21;  382/                                       2017-01-09; 384                                        2017-02-06; 386                                        2017-03-24 ; 388                                        2017-05-14 ; 390                                        2017-06-12 .  And all future lots until the issue is resolved. Siemens will also include a notecard in future lots of reagents referring customers to the communications .",
      "firm_fei_number": "1219913",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc",
      "address_1": "333 Coney St",
      "city": "East Walpole",
      "state": "MA",
      "postal_code": "02032-1516",
      "additional_info_contact": "508-668-5000",
      "reason_for_recall": "CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the ADVIA Centaur/XP/XPT\nsystems as stated in the Instructions for Use.",
      "root_cause_description": "Process design",
      "action": "Siemens Healthcare issued Urgent Medical Device Correction (UMDC) to Siemens Healthcare Diagnostics customers in the United States on October 19, 2016 to be delivered to customers on October 20, 2016. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on October 18, 2016. The notice informs the customer of the potential to observe a bias between CA 19-9 results generated on the ADVIA Centaur CP and the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems. Customers may continue\nto use the ADVIA Centaur CA 19-9 assay to report patient results on the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT and ADVIA Centaur CP systems. Customers should not use the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems interchangeably with the ADVIA Centaur CP when generating CA 19-9 results.\nFor customers using the ADVIA Centaur CP and ADVIA Centaur/XP/XPT for CA 19-9 interchangeably, a look back of patient results over the previous three months is recommended.\n\nA Field Correction Effectiveness Check is to be completed, signed and returned Siemens.  \n\nQuestions, contact your Siemens Customer Care Center or your local Siemens technical support representative.",
      "product_quantity": "18,733 kits",
      "distribution_pattern": "Nationwide\nForeign:\nAlbania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Germany, Great Britain, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy,\nJapan, Jordan, Kazakhstan, Latvia, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uruguay, Vatican City, Vietnam",
      "openfda": {
        "k_number": [
          "K020566",
          "K033038",
          "K253528",
          "K023239",
          "K191973",
          "K052889",
          "K231525",
          "K200997",
          "K031393",
          "K052000",
          "K023240",
          "K100375"
        ],
        "registration_number": [
          "2432235",
          "9612316",
          "8031673",
          "2020726",
          "3005360469",
          "2521625",
          "3005529799",
          "3002642396",
          "3002809144",
          "3007111389",
          "1219913",
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          "8020888",
          "3000308930",
          "1319681",
          "3005333358",
          "2032839",
          "3012963943"
        ],
        "fei_number": [
          "3002808328",
          "2432235",
          "3005670738",
          "3002806559",
          "2020726",
          "2521625",
          "3005529799",
          "3002642396",
          "3002809144",
          "3007111389",
          "1219913",
          "3004185580",
          "2122870",
          "2250051",
          "1000136573",
          "2517506",
          "3000308930",
          "2967",
          "3005333358",
          "3012963943",
          "3007019572"
        ],
        "device_name": "System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.6010",
        "device_class": "2"
      }
    }
  ]
}