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-00389-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00389-1
  • 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 confirmation that the advia centaur br (ca 27.29) assay does not dilute linearly when used with multi-diluent 1 kit. when diluted, some samples over-recover the expected neat value by greater than 120%. dilution of samples with results greater than the analytical measuring range for the advia centaur br (ca 27.29) assay may be important for serial measurements during treatment.
  • Action
    Siemens is requesting users to discontinue dilution of samples using the ADVIA Centaur systems BR (CA 27.29) with Multi-Diluent 1 kit lots ending in 2577 and future lots of Multi-Diluent 1 until further notice. Users are advised to contact their local Siemens Customer Care Centre or their local Siemens technical support representative if they receive any complaints of illness or adverse events associated with the affected products.

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 respectivelyLots ending in 2577 and all future lotsSystems affected: ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CPARTG Number: 175636
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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