Events

Recall of ADVIA Centaur/Centaur XP/ Centaur CP HBcTotal (HBcT) Kits. 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 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-2012-RN-01138-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-11-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01138-1
  • 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 diagnostics has received complaints regarding a perceived increased rate of reactive results that do not correspond with other hbv serological markers. reagent lots ending in 044, 045 and 046 do not meet the specificity claims of 99.75% (5130/5143) with a 95% confidence interval (ci) of 99.57 to 99.87% as described in the instructions for use (ifu) for the hbct assay when used on advia centaur systems.
  • Action
    Discontinue and discard affected lots. Affected lots will be replaced by Siemens Ltd.

Device

ADVIA Centaur/Centaur XP/ Centaur CP HBcTotal (HBcT) Kits. An in vitro diagnostic medical device ...
  • Model / Serial
    ADVIA Centaur/Centaur XP/ Centaur CP HBcTotal (HBcT) Kits. An in vitro diagnostic medical device (IVD)Siemens Material Number: 10309508Product Number: 07566733Multiple lot numbers affectedARTG Number: 93126
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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