Events

Recall of Oxoid Antimicrobial Susceptibility Testing Discs for Gentamicin (CN10). 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-2013-RN-00173-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-02-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00173-1
  • 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 have confirmed that cartridges within this batch may contain individual discs that are not impregnated with antibiotic. this could lead to a false indication of resistance to gentamicin.
  • Action
    Thermo Fisher Scientific is requesting customers to inspect stock and remove any affected units from further use. A credit note will be issued once affected stock has been confirmed. This action has been closed-out on 12/02/2016.

Device

Oxoid Antimicrobial Susceptibility Testing Discs for Gentamicin (CN10). An in vitro diagnostic me...

Manufacturer

Thermo Fisher Scientific Australia & New Zealand