Events

Recall of Oxoid Anti-microbial Susceptibility Testing Disc CT0024B Gentamicin (CN 10) 5x50 discs

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-2015-RN-01078-1
  • Event Risk Class
    Class II
  • 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-01078-1
  • 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
    Some discs in the affected lot may have insufficient concentration of antibiotic. this could result in an incorrect test reading due to small or absent zones of inhibition. continued use of this lot could result in quality control failures, delayed results or false resistance reporting.
  • Action
    End users are requested to inspect their stock for affected units. Affected units are to be removed from further use. The requirement for the review of patient results should be determined by the laboratory director. This action has been closed-out on 06/06/2016.

Device

Oxoid Anti-microbial Susceptibility Testing Disc CT0024B Gentamicin (CN 10) 5x50 discs

Manufacturer

Thermo Fisher Scientific Australia & New Zealand