Events

Recall of Bond Polymer Refine Red Detection System. An in vitro diagnostic medical device (Immunohisto chemical staining kit)

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-2013-RN-00824-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-08-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00824-1
  • 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 has received reports that the product may be contaminated with fungus. this issue could cause loss of staining sensitivity or obstruction of fluid delivery to the slide.
  • Action
    Leica Biosystems is requesting users to remove and discard remaining affected reagents. Affected product will be replaced by Leica Biosystems. A review of patient results reported from the affected lot should be undertaken at the discretion of the laboratory manager.

Device

Bond Polymer Refine Red Detection System. An in vitro diagnostic medical device (Immunohisto chem...
  • Model / Serial
    Bond Polymer Refine Red Detection System. An in vitro diagnostic medical device (Immunohisto chemical staining kit)Catalogue Number: DS9390Lot Numbers: 22017
  • Manufacturer
    Leica Biosystems Melbourne Pty Ltd

Manufacturer

Leica Biosystems Melbourne Pty Ltd