Events

Recall of HIV Ag/Ab Combo (CHIV) Assay (used with ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP) (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-2013-RN-00984-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-09-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00984-1
  • 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 has determined that not all distributed lots would meet the performance criteria as currently described in the instructions for use (ifu) with respect to the analytical sensitivity. siemens are updating the labelling to better reflect the observed and potential range of assay performance with respect to this parameter (i.E less than and equal to 2.0 iu/ml).
  • Action
    Siemens is providing work around instructions for users to follow until the revised Instructions for Use (IFU) are released.

Device

HIV Ag/Ab Combo (CHIV) Assay (used with ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP) (an...
  • Model / Serial
    HIV Ag/Ab Combo (CHIV) Assay (used with ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP) (an in vitro diagnostic medical device (IVD))Catalogue Number: 06520528Siemens Material Number: 10283020Multiple lot numbers affectedARTG Number: 205090
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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