Events

Recall of ADVIA Centaur BR Assay for CA 27.29, ADVIA Centaur BR Assay for CA 15-3. An in vitro diagnostic devices (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens 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-2012-RN-00905-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-09-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00905-1
  • 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
    An onboard stability issue is resulting in an out of specification calibration interval potentially giving rise to false positive results.
  • Action
    Siemens is providing work around instructions for users to follow. This action has been closed-out on 16/02/2017.

Device

ADVIA Centaur BR Assay for CA 27.29, ADVIA Centaur BR Assay for CA 15-3. An in vitro diagnostic d...
  • Model / Serial
    ADVIA Centaur BR Assay for CA 27.29, ADVIA Centaur BR Assay for CA 15-3. An in vitro diagnostic devices (IVD)ADVIA Centaur BR Assay for CA 27.29Reference numbers: 03896216 and 02419937ADVIA Centaur BR Assay for CA 15-3Reference numbers: 01157807 and 03204829Multiple lot numbers
  • Manufacturer
    Siemens Ltd

Manufacturer

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