{
  "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": "71337",
      "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 - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, MS, MT, NC, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, WV, and Puerto Rico; and the countries of Algeria, Austria, Bahrain, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, Iceland, Indonesia, Ireland, Italy, Jordan, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, Norway, Pakistan, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates,  AR, AU, BD, BR, CA, CL, CN , CO, CR, DO, EC, HK, ID, IE, IL, IN, JP, KR, LK, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, TH, TW, UY, VN, and ZA.",
      "recall_number": "Z-2207-2015",
      "product_description": "ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests    Product Usage:  For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP systems. Cardiac troponin I determinations aid in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures.",
      "product_quantity": "SMN10317708 = 20544 kits & SMN 10317709 = 21159 kits",
      "reason_for_recall": "System-to-system bias between the Tni-Ultra assay on  the ADVIA Centaur CP and ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems.",
      "recall_initiation_date": "20150519",
      "center_classification_date": "20150723",
      "termination_date": "20190717",
      "report_date": "20150729",
      "code_info": "***This field action applies to all in-date lots of reagents (Kit lots ending in 088, 089, 090, 091, 093 and 094) and all future lots until the issue is resolved and a follow-up communication is issued by Siemens.****    SMN 10317708 - 100 tests  43796099 May 25, 2015  43818088 May 25, 2015  44793088 May 25, 2015  45687089 June 22, 2015  46527089 June 22, 2015  48096089 June 22, 2015  49216090 August3, 2015  50779090 August3, 2015  52113091 September 14, 2015  53091093 October 19, 2015  54684093 October 19, 2015    SMN 10317709 -500 tests  43797088 May25, 2015  43819088 May25,2015  44098088 May25, 2015  44623088 May 25, 2015  45688089 June 22, 2015  46661089 June 22, 2015  48301090 August3, 2015  49869090 August 3, 2015  50884091 September 14, 2015  51471091 September 14, 2015  51798091 September 14, 2015  53092093 October 19,2015  53231093 October 19,2015  54742094 December 6, 2015"
    }
  ]
}