{
  "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-0507-2013",
      "product_description": "Siemens Healthcare BR Assay for CA 27.29  250 Test Kits 03896216  50 Test Kit 02419937  Ref Kit (US only) 10340081      Intended Use The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur and ADVIA Centaur XP systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage Ill breast cancer.",
      "product_quantity": "250 test =1678 and 50 test =2660 and Ref. 1196",
      "reason_for_recall": "Operating range of the ADVIA Centaur systems is 18¿C 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"
    }
  ]
}