Events

Recall of DR0850M, Oxoid Staphytect plus 100 tests (used for the identification of Staphlococcus aureus). 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 Thermo Fisher Scientific Australia & New Zealand.

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-2012-RN-01195-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-11-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01195-1
  • 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
    Investigations by the manufacturer have confirmed that test latex within this batch may present an atypical agglutination reaction resulting in a false positive interpretation. continued use of this lot could result in false identification of staphylococcus aureus.
  • Action
    Quarantine and remove affected units form use.

Device

DR0850M, Oxoid Staphytect plus 100 tests (used for the identification of Staphlococcus aureus). A...

Manufacturer

Thermo Fisher Scientific Australia & New Zealand