{
  "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": "105596",
      "product_res_number": "Z-0489-2012",
      "event_date_initiated": "2011-11-11",
      "event_date_posted": "2012-01-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-04-12",
      "res_event_number": "60502",
      "product_code": "NIG",
      "product_description": "ADVIA Centaur CA19-9 Assay\nCat. Nos.\n123521 (03481938) - 250 Test kit w/o Calibrators\n123519 (04612750) - 50 Test kit w/o Calibrators\n10491244 - 250 Test kit w/Calibrators\n10491379 - 50 Test kit w/Calibrators\n\nThe ADVIA Centaur CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The test is useful as an aid in monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of serum CA 19-9 at some point in their disease process exceeding the median concentration determined for the apparently healthy cohort. CA 19-9 values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is determined.",
      "code_info": "Reagent Lot #\tExpiry Date XXXXX294\t                 11-Aug-11 XXXXX296\t                    6-Oct-11 XXXXX298\t                    6-Nov-11 XXXXX299\t                    6-Nov-11 XXXXX302\t                    9-Jan-12 XXXXX303\t                    9-Jan-12 XXXXX305\t                18-Feb-12 XXXXX306\t                  3-Apr-12 XXXXX307\t                  3-Apr-12 XXXXX308\t                  3-Apr-12 XXXXX309\t                  3-Jun-12 XXXXX311\t                 30-Jun-12",
      "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": "Same\n508-359-3825",
      "reason_for_recall": "Positive bias of 14% and higher for some individual points for CA 19-9 results generated on the ADVIA Centaur CP system when they are compared to CA 19-9 assay results generated on either the ADVIA Centaur or ADVIA Centaur XP systems",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Siemens Healthcare Diagnostics issued a Urgent Device Notification email dated  November 11, 2011, to all affected customers.  The letter identified the product the problem and the action needed to be taken by the customer.\n\nThe letter instructed the  customers conduct a look back if they are using the ADVIA Centaur CA 19-9 interchangeably with the ADVIA Centaur or ADVIA Centaur XP systems and the ADVIA Centaur CP system and to review the contents of the recall notice with their Laboratory Director. A confirmation fax-back form is included to ensure that all customers worldwide have been notified and have complied with the mandatory action\n\nFor further questions please call  (508)  359.3825.",
      "product_quantity": "50 Test Kits =21,160; 250 Test Kits = 21,593",
      "distribution_pattern": "Worldwide Distribution -- USA (nationwide) and the countries of  Australia, Malyasia, Korea, Hong Kong, Singapore, Myanmar, Mexico, Egypt, Taiwan, South Africa, Brazil ,India, Japan, Argentina, Chile, Peru, Germany, Malaysia, Saudi Arabia, and Canada.",
      "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",
          "9610126",
          "2122870",
          "2250051",
          "2517506",
          "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"
      }
    }
  ]
}