Events

Recall of Oxoid Antimicrobial Susceptibility Testing Discs - Ticarcillin/Clavulanic Acid (TIM85 Timetin). 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-2016-RN-00393-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00393-1
  • 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
    Internal investigations by oxoid limited have identified variability in concentration of certain lots of timetin tim85. active compound degradation over the shelf life may result in lower than specified concentration leading to out of specification performance results (small zone size).Continued use of this product could result in delayed or false resistance reporting.
  • Action
    Thermo Fisher Scientific is advising users to inspect stock and remove any remaining stocks of the affected product from use. Please complete the reply form and return in order for a credit note to be issued.

Device

Oxoid Antimicrobial Susceptibility Testing Discs - Ticarcillin/Clavulanic Acid (TIM85 Timetin). A...
  • Model / Serial
    Oxoid Antimicrobial Susceptibility Testing Discs - Ticarcillin/Clavulanic Acid (TIM85 Timetin). An in vitro diagnostic medical device (IVD).Product Code: CT0449BAll lots affectedARTG Number: 208273
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand