Events

Recall of Xpert HIV-1 Viral Load Assay. 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 Cepheid Holdings 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-2016-RN-01272-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-10-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01272-1
  • 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
    Cepheid has received reports that some customers have experienced cartridge performance issues that manifest as abnormal pcr amplification curve patterns, which can yield invalid results (the most common outcome), or much less commonly, inaccurate quantification of hiv-1 rna when using this test and its intended use specimen types.
  • Action
    Cepheid is advising users to stop using and dispose of any remaining product from the affected lot (Lot Number 1000034821). Replacement product will be provided. The results of previous tests performed with this lot of product should be discussed with the laboratory medical director to determine whether a look-back is required. If there are any concerns about the accuracy of the results contact Cepheid Technical Support who will analyse the GeneXpert data files (gxx files). This action has been closed-out on 10/05/2017.

Device

Xpert HIV-1 Viral Load Assay. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    Xpert HIV-1 Viral Load Assay. An in vitro diagnostic medical device (IVD).Catalogue Number: GXHIV-VL-CE-10 Lot Number: 1000034821 (Cartridge Lot: 14001)Expiration Date : 09 October 2016ARTG Number: 259967
  • Manufacturer
    Cepheid Holdings Pty Ltd

Manufacturer

Cepheid Holdings Pty Ltd