Events

Recall of Hydrochloric Acid 6 Molar 30mL Containers. 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-2018-RN-00489-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-05-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00489-1
  • 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 scientific has identified that the plain container patient information label adhered to specimen jars for specific lots is incorrect as it contains the phrase "10% neutral buffered formalin". the correct label is exactly the same, but without the "10% neutral buffered formalin" phrase. the product information on the box (contains the containers) and content label on the containers are correct.
  • Action
    Thermo Fisher is advising customers to identify and quarantine affected product. Thermo Fisher will contact users to arrange replacement or credit of stock.

Device

Hydrochloric Acid 6 Molar 30mL Containers. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Hydrochloric Acid 6 Molar 30mL Containers. An in vitro diagnostic medical device (IVD)Catalogue Number: FNNHCL/30Lot Numbers: 1708249410 and 1803258790ARTG Number: 243713(Thermo Fisher Scientific Australia - Specimen receptacle IVDs)
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd