Events

Recall of ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP - Troponin Ultra Ready

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-2014-RN-00608-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-06-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00608-1
  • 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
    Manufacturer confirms that the solid phase reagent in some of the advia centaur tni-ultra readypacks, lot 084, is darker in appearance, creating a potential for incorrect control and patient results.
  • Action
    Siemens is providing work around instructions to users. Only one TNI-Ultra ReadyPack is to be used on a system at one time. Patient results produced by the assay are acceptable if they follow acceptable calibration with valid quality control results. Kit lots ending in 086 or higher do not require calibration of each ReadyPack, refer IFU for the calibration interval. This action has been closed-out on 11/04/2016.

Device

ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP - Troponin Ultra Ready
  • Model / Serial
    ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP - Troponin Ultra ReadyPack. An in vitro diagnostic medical device (IVD).Catalogue Numbers: 02789602 (100 tests) and 02790309 (500 tests)Lot Numbers:Kit Lots ending in 078Expiration: 18 July, 2014Kit Lots ending in 079Expiration: 18 July 2014Kit Lots ending in 082Expiration: 27 September, 2014Kit Lots ending in 083Expiration: 29 November, 2014Kit Lots ending in 084Expiration: 28 December 2014
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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