Events

Recall of QConnect HBVNAT Positive

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Thermo Fisher Scientific Australia 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-2015-RN-01050-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-11-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01050-1
  • 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
    Certain lot numbers of the qconnect hbvnat positive control may give no results due to ic (internal control) failure when run on the abbott m2000.The affected lot numbers should not be run on the abbott m2000.To ensure all affected lots have been destroyed the respective product specialist for each area will visit each site to confirm there is no stock still in possession.
  • Action
    Users are asked to quarantine all affected units from use prior to destruction. To ensure all affected lots have been destroyed the respective Product Specialist for each area will visit each site to confirm there is no stock still in possession. This action has been closed-out on 22/08/2016.

Device

QConnect HBVNAT Positive

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd