{
  "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": "2026-04-15",
    "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": "75523",
      "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": "Nationwide  Foreign:  Albania, 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,  Japan, 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",
      "recall_number": "Z-0613-2017",
      "product_description": "ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with  the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems.  Siemens Material Number(SMN): 10491244    In 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 FDA\u0019s Reagent Replacement Policy.  Siemens plans to request CLIA Categorization for the CA19-9 assay on XPT the week of 11/21/2016.",
      "product_quantity": "30,222 kits",
      "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  systems as stated in the Instructions for Use.",
      "recall_initiation_date": "20161019",
      "center_classification_date": "20161117",
      "termination_date": "20230302",
      "report_date": "20161123",
      "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."
    }
  ]
}