Events

Recall of TnI-Ultra (Troponin) Assay, 100 and 500 tests (used in the determination of cardiac troponin). An in vitro diagnostic medical device (IVD) Systems affected: ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT, ADVIA Centaur CP

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare Pty Ltd.

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
    RC-2016-RN-00603-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-05-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00603-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Siemens healthcare laboratory diagnostics has confirmed that all in date lots of advia centaur tni-ultra exhibit a greater than 10% change in results in samples with biotin levels up to 10 ng/ml (41 nmol/l). the instructions for use (ifu) states that specimens that have up to 10 ng/ml (41 nmol/l) of biotin demonstrate = 10% change in results. the biotin level in a general population is approximately 0.3 to 1.0 ng/ml (1.2 to 4.3 nmol/l).The biotin interference is proportionate across tni concentrations; therefore, the ability of the assay to detect serial increases or decreases of tni is maintained.
  • Action
    Siemens is advising users that the Tnl-Ultra assay can continue to be used, however, users should be aware that patients who are taking biotin supplements may exhibit a slightly elevated TnI-Ultra result; however, the ability of the assay to detect serial increases or decreases of TnI is maintained. A review of previously generated results is at the discretion of the Laboratory Director.

Device

TnI-Ultra (Troponin) Assay, 100 and 500 tests (used in the determination of cardiac troponin). An...
  • Model / Serial
    TnI-Ultra (Troponin) Assay, 100 and 500 tests (used in the determination of cardiac troponin). An in vitro diagnostic medical device (IVD)Systems affected: ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT, ADVIA Centaur CP Catalogue Numbers: 02789602, 02790309Siemens Material Numbers (SMN): 10317708, 10317709Multiple Lot Numbers affectedARTG Number: 175197
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA