Events

Recall of Device Recall ADVIA Centaur TnIUltra Assay

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

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
    44725
  • Event Risk Class
    Class 2
  • Event Number
    Z-0580-2008
  • Event Initiated Date
    2007-06-07
  • Event Date Posted
    2008-06-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64326
  • 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
    in vitro diagnostic (Troponin) - Product Code MMI
  • Reason
    Incorrect results: falsely elevated troponin values have been reported which are inconsistent with the patient's clinical picture and test negative by other troponin assays.
  • Action
    Two Support Bulletins (078N0361-01 & 078N0361-02) were sent by e-mail to all affected Siemens Diagnostics Branches to inform them of this issue. The first one was sent on 6/07/07 and the second one was sent on 7/05/07. Two Customer Bulletins (078D0647-01 & 078D0651-01) were sent by e-mail to the Siemens Diagnostics Branches for communication with the affected customers. The first one was sent on 6/07/07 and the second one was sent on 7/05/07. These bulletins state that if a false positive is suspected, the sample should be diluted and retested.

Device

Device Recall ADVIA Centaur TnIUltra Assay
  • Model / Serial
    All lots. 500 tests: Part/Catalog #02790309, and 100 tests: Part/Catalog # 02789602.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA, Argentina, Austria, Australia, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Greece, Hong Kong, India, Israel, Italy, Malaysia, Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela
  • Product Description
    ADVIA Centaur TnI-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog # 02790309, and 100 tests - Part/Catalog # 02789602. For in vitro diagnostic use, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591
  • Manufacturer
    Siemens Medical Solutions Diagnostics

Manufacturer

Siemens Medical Solutions Diagnostics
  • Manufacturer Address
    Siemens Medical Solutions Diagnostics, 511 Benedict Avenue, Tarrytown NY 10591-5005
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA