Events

Recall of Oxoid Antimicrobial Susceptibility Testing Discs TIM85(Timentin), CT0449B

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-00094-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-02-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00094-1
  • 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
    Cartridges within the affected batch may contain some discs with a degraded or insufficient level of ingredient (clavulanic acid). a technical investigation confirmed that discs within this lot may have insufficient concentration of ticarcillin/clavulanic acid potentially resulting in below specification zones of inhibition. continued use of this lot could result in a false indication of resistance to timentin.
  • Action
    Customers are advised to inspect stock on hand and and to remove from further use all affected units. On receipt of the Reply Form ThermoFisher will issue a credit note. This action has been closed-out on 24/05/2016.

Device

Oxoid Antimicrobial Susceptibility Testing Discs TIM85(Timentin), CT0449B

Manufacturer

Thermo Fisher Scientific Australia & New Zealand