Events

Recall of ADVIA Centaur TnI-Ultra

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

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-2015-RN-00442-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-05-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00442-1
  • 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 diagnostics has observed a system-to-system bias between the tni-ultra assay on the following systems:- advia centaur cp and - advia centaur- advia centaur xp- advia centaur xpt the advia centaur cp is generating lower results than the advia centaur/advia centaurxp/advia centaur xpt system. siemens is actively pursuing the cause of this issue.
  • Action
    Siemens is providing end users with information to assist with the interpretation and release of troponin results. Siemens internal investigation has confirmed the clinical utility of the assay at the 99th percentile for healthy individuals (0.02 - 0.06 ng/mL (µg/L)) is not impacted by this issue.

Device

ADVIA Centaur TnI-Ultra
  • Model / Serial
    ADVIA Centaur TnI-UltraSiemens Material Numbers: 10317708 and 10317709Lots numbers ending in 088, 089, 090, 091, 093 and 094 and all future lots until issue is resolvedARTG number: 175197An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA