Events

Recall of Dengue NS1 Ag Strip

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Bio-Rad Laboratories 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-01238-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01238-1
  • 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
    There has been a sudden degradation of the sensitivity of certain lots of dengue ns1 ag strips, which has resulted in false negative results for positive patient samples.
  • Action
    Bio-Rad is advising users to inspect stock (including units currently in use) and discard the affected units. Affected lots will be replaced. This action has been closed-out on 30/08/2016.

Device

Dengue NS1 Ag Strip
  • Model / Serial
    Dengue NS1 Ag StripCatalogue Number: 70700Serial/Lot Numbers:5F0130 Expiry Date: 30 March 20165H0131 Expiry Dates: 30 April 2016 and 15 May 20165H1131 Expiry Dates: 30 April 2016 and 15 May 20165H2131 Expiry Dates: 30 April 2016 and 15 May 2016ARTG Number: 207118An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd