Events

Recall of ADVIA Centaur BR Assay (50 and 250 tests). An in vitro diagnostic medical device (IVD)

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-2017-RN-00387-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00387-1
  • 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
    There is a potential for the advia centaur syphilis assay to interfere with the br (ca 27.29) assay on the advia centaur systems. (this only occurs when the syphilis assay immediately precedes the br assay on the advia centaur, advia centaur xp or advia centaur xpt systems.) syphilis interference may cause controls to recover low out of range for the advia centaur br assay. siemens evaluated br patient samples within the analytical measuring range and br samples above the analytical measuring range (> 450 u/ml) between 5,875 u/ml & 11,443 u/ml. advia centaur br patient samples below 221 u/ml are unaffected. advia centaur br patient samples above the analytical measuring range may recover on curve as low as 200 u/ml. a falsely low result during serial monitoring of treatment response when the true value is stable/increasing may lead to a delay in detection of cancer progression.Current & future lots of advia centaur systems br reagents are affected until implementation of a solution.
  • Action
    Siemens is requesting customers to refer to their recall notification letter to ascertain the ways their system is affected and to follow the appropriate instructions on how to correct their systems. Customers are advised to immediately contact their local Siemens Customer Care Centre or their local Siemens technical support representative, if they have received complaints of illness or adverse events associated with the products. Customers are further advised to review the recall notification letter with their medical director.

Device

ADVIA Centaur BR Assay (50 and 250 tests). An in vitro diagnostic medical device (IVD)
  • Model / Serial
    ADVIA Centaur BR Assay (50 and 250 tests). An in vitro diagnostic medical device (IVD)Catalogue Numbers: 02419937 (116734) and 03896216 (116735) respectivelySiemens Material Numbers (SMN): 10333349 and 10334837 respectivelyAll Lot NumbersSystems affected: ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPTARTG Number: 175636
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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