Events

Recall of Non Buffered Formalin. 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 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-2015-RN-01139-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-11-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01139-1
  • 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
    Investigations have confirmed that certain lots of non buffered formalin have had incorrect labelling placed on the bottles. the bottles have been labelled as 10% neutral buffered formalin, rather than non buffered formalin. this issue is unlikely to cause adverse health consequences.
  • Action
    Thermo Fisher is advising the users to inspect stock and quarantine the affected units prior to their return to the sponsor. This action has been closed-out on 18/08/2016.

Device

Non Buffered Formalin. An in vitro diagnostic medical device (IVD)

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd