Events

Recall of Bond Ready-To-Use Primary Antibody Thyroglobulin (1D4) (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 Leica Biosystems Melbourne 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-2014-RN-00476-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-04-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00476-1
  • 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
    Leica biosystems recently became aware that the affected product does not function as intended up to the expiry date on the product labelling. this was detected through stability monitoring carried out by leica biosystems. there is a link between the age of the product and staining intensity.
  • Action
    Leica is requesting their customers to destroy any unused reagent from lot 24963 and confirm that the affected product is no longer in use.

Device

Bond Ready-To-Use Primary Antibody Thyroglobulin (1D4) (An in vitro Diagnostic Medical Device (IVD)

Manufacturer

Leica Biosystems Melbourne Pty Ltd