Events

Recall of ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CPADVIA Centaur Systems TSH3 Ultra 100T, 500T

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-00441-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-04-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00441-1
  • 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 has confirmed that samples containing fluorescein (dye commonly used in fluroescein angiography) may show interference with the advia centaur systems tsh3 ultra, vitamin d and the advia centaur brahms procalcitonin assays.
  • Action
    Siemens is notifying their customers of the potential for samples with fluorescein to show interference and the Instructions for Use are currently being updated.

Device

ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CPADVIA Centaur Systems TSH3 Ultra 100T, 500T
  • Model / Serial
    ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CPADVIA Centaur Systems TSH3 Ultra 100T, 500TCatalogue No: 06491072 & 06491080Kit Lots Ending In: 266, 267, 269, 270, 271, 272 & 273ADVIA Centaur Systems VitD 100T, 500TCatalogue No: 10491994, 10699201, 10631021 & 10699533Kit Lots Ending In: 023, 024, 025, 026, 027, 050, 051, 052, 053 & 054ADVIA Centaur BRAHMS PCT 100TCatalogue No: 10378883Kit Lots Ending In: 020, 021, 022, 023 & 024ARTG No: 175698 & 175700
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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