Events

Recall of Kleihauer

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-2017-RN-00814-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-06-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00814-1
  • 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 a batch of kleihauer which has been labelled with an incorrect expiry date. the expiry date on outer kit labelled (january 2018) is different to the expiry date on individual bottles inside the kit. the individual bottles are labelled with the expiry date (january 2017). the correct expiry date for the product is june 2017.
  • Action
    Users are asked to inspect stocks and quarantine all units fro the affected lot number. Thermo Fisher will recover the affected stock and provide a replacement or a credit note.

Device

Kleihauer

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd