Events

Recall of ADVIA Centaur Homocysteine (HCY) Assay used with the ADVIA Centaur, Centaur XP, and Centaur CP systems

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-2013-RN-00672-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-07-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00672-1
  • 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 have identified that the percent recovery for 1:10 diluted patient sample dilutions is lower than reported in the instructions for use (ifu). dilution of patient samples is primarily used to resolve results above the diagnostic range of the hcy assay.
  • Action
    Siemens is advising end users to ensure that 1:10 sample dilution testing is no longer carried out. The performance of 1:2 sample dilutions has been confirmed to meet the IFU recoveries and can continue to be tested. This action has been closed-out on 07/09/2016.

Device

ADVIA Centaur Homocysteine (HCY) Assay used with the ADVIA Centaur, Centaur XP, and Centaur CP sy...
  • Model / Serial
    ADVIA Centaur Homocysteine (HCY) Assay used with the ADVIA Centaur, Centaur XP, and Centaur CP systemsMultiple Catalogue numbers and Lot numbers affectedARTG Number: 175075 An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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