Events

Recall of CT1133S Cephalexin 100ug CL100 Antimicrobial Susceptibility Discs (Used for antimicrobial susceptibility testing)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Oxoid 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-2012-RN-00694-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-07-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00694-3
  • 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
    The manufacturer's investigations confirmed that some cartridges within this batch may contain individual discs that are not sufficiently dosed with antibiotic. continued use of this lot could therefore result in false indication of resistance.
  • Action
    Remove all affected lots from use and return to Oxoid Australia. This action has been closed-out on 02/02/2016.

Device

CT1133S Cephalexin 100ug CL100 Antimicrobial Susceptibility Discs (Used for antimicrobial suscept...
  • Model / Serial
    CT1133S Cephalexin 100ug CL100 Antimicrobial Susceptibility Discs (Used for antimicrobial susceptibility testing), An in vitro diagnostic medical device (IVD)Batch Number: 1129970
  • Manufacturer
    Oxoid Australia Pty Ltd

Manufacturer

Oxoid Australia Pty Ltd