{
  "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": "2026-04-22",
    "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": "63682",
      "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": "Worldwide Distribution - USA (nationwide) and Internationally to the following countries:   Argentina  Australia  Austria  Azerbaijan  Belgium  Bosnia Herzeg.  Brazil  Canada  Chile  COLOMBIA  Croatia  Czech Republic  Denmark  Egypt  Estonia  Finland  France  Germany  Greece  Hong Kong  Hungary  Iceland  India  Indonesia  Iran  Ireland  Italy  Japan  Kazakhstan  Latvia  Lithuania  Malaysia  Mexico  Netherlands  New Caledonia  Norway  Oman  P.R. China  Philippines  Poland  Portugal  Qatar  Rep. of Yemen  Republic Korea  Reunion  Romania  Russian Fed.  Saudi Arabia  Serbia  Slovakia  Slovenia  South Africa  Spain  Sweden  Switzerland  Taiwan  Thailand  Turkey  U.A.E.  United Kingdom  Uruguay  Vietnam",
      "recall_number": "Z-0508-2013",
      "product_description": "Siemens Healthcare  ADVIA Centaur CA 19-9  250 Test 10491244  50 Test 10491379    Intended Use The 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.",
      "product_quantity": "250 test=525 and 50 test=12243",
      "reason_for_recall": "Operating range of the ADVIA Centaur systems is 18C to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.",
      "recall_initiation_date": "20121114",
      "center_classification_date": "20121211",
      "termination_date": "20150925",
      "report_date": "20121219",
      "code_info": "All lot codes"
    }
  ]
}