Events

Recall of Thioglycollate Broth 5mL. 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-2014-RN-01152-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-10-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01152-1
  • 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
    Thermo fisher's investigations found that some vials within some boxes within this batch may fail to support the growth of clostridium sporogenes.Continued use of this lot could result in failure to detect this or similar anaerobes.
  • Action
    Pathology laboratories are requested to inspect their stocks and remove from further use all units from the affected batch number. Requirement for review of patient results should be determined by the laboratory director. This action has been closed-out on 03/06/2016.

Device

Thioglycollate Broth 5mL. An in vitro diagnostic medical device (IVD)

Manufacturer

Thermo Fisher Scientific Australia & New Zealand