Events

Recall of Red top histology jars containing 10% Neutral Buffered Formalin Solution. 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-2016-RN-01108-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-08-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01108-1
  • 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 by thermo fisher scientific have confirmed that an error in jar labelling has occurred in certain lots of red top histology jars (with formalin) for tissue specimens. correct label:“tissue specimen” “poison – contains 10% buffered formalin”incorrect label:“specimen container for urine, sputum, semen, etc” poison statement missing.
  • Action
    Thermo Fisher is advising users to inspect stock and return the affected stock for replacement with unaffected product. This action has been closed-out on 15/02/2017.

Device

Red top histology jars containing 10% Neutral Buffered Formalin Solution. An in vitro diagnostic ...
  • Model / Serial
    Red top histology jars containing 10% Neutral Buffered Formalin Solution. An in vitro diagnostic medical device (IVD)Code: FNNNBF/30CAPITALBatch Numbers: 1508201420, 1508201420, 1606220560ARTG Number: 243713
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd