Events

Recall of Xpert HIV-l Viral LoadAn in vitro medical device

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-2018-RN-00012-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-01-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00012-1
  • 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
    Since beginning of 2017, three incidents of discrepant results were reported to the european competent authorities involving the xpert hiv-l viral load test and other alternative methods where the xpert hiv-1 viral load assay did not detect the variant of hiv.
  • Action
    Cepheid recommends that each user of the Xpert HIV-l Viral Load test is informed about the update of the package insert which is now including the following additional limitation: “Rare mutations within the target region of the HIV-1 VL assay may affect primer and/or probe binding resulting in under-quantitation of virus.”

Device

Xpert HIV-l Viral LoadAn in vitro medical device
  • Model / Serial
    Xpert HIV-l Viral LoadAn in vitro medical deviceCatalogue number - GXHIV-VL-CE-10ARTG Number 259967 (Cepheid Holdings Pty Ltd - Human immunodeficiency virus (HIV) IVDs)
  • Manufacturer
    Cepheid Holdings Pty Ltd

Manufacturer

Cepheid Holdings Pty Ltd