Events

Recall of Device Recall ADVIA Centaur TnIUltra

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71337
  • Event Risk Class
    Class 2
  • Event Number
    Z-2207-2015
  • Event Initiated Date
    2015-05-19
  • Event Date Posted
    2015-07-23
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137330
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Immunoassay method, troponin subunit - Product Code MMI
  • Reason
    System-to-system bias between the tni-ultra assay on the advia centaur cp and advia centaur/advia centaur xp/advia centaur xpt systems.
  • Action
    Siemens sent an Urgent Medical Device Correction letter dated via Federal Express to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Field Correction Effectiveness Check attached to the letter. For questions contact your Siemens Customer Care Center or your local Siemens technical support representative.

Device

Device Recall ADVIA Centaur TnIUltra
  • Model / Serial
    ***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
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • 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.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc

Manufacturer

Siemens Healthcare Diagnostics, Inc
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA