Events

Recall of ADVIA Centaur Multi-Diluent 1 supplied with ADVIA Centaur BNP kit and ADVIA Centaur TSH-3 Ultra kit; 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-00765-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-07-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00765-3
  • 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 confirmed a decrease in onboard dilution recovery when using multi-diluent 1 that has been stored on board the advia centaur and advia centaur xp systems. this under-recovery has been observed in plasma samples with high bnp and tsh-3 values that require dilution to achieve results within the reportable range on the advia centaur and advia centaur xp systems.
  • Action
    Siemens is providing work around instructions for users to follow.

Device

ADVIA Centaur Multi-Diluent 1 supplied with ADVIA Centaur BNP kit and ADVIA Centaur TSH-3 Ultra k...
  • Model / Serial
    ADVIA Centaur Multi-Diluent 1 supplied with ADVIA Centaur BNP kit and ADVIA Centaur TSH-3 Ultra kit; An in vitro diagnostic medical device (IVD)REF: 2 pack - 07293184 (110312) and 6 pack - 0790714 (110313)Multiple Lot Numbers Supplied with:ADVIA Centaur BNP kitREF: 02816634 and 02816138ADVIA Centaur TSH-3 Ultra kitREF: 06491080 and 06491072
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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