Events

Recall of Polymer Refine Red Detection (used for testing and identification of neoplasm). 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-2015-RN-01206-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01206-1
  • 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 some detection kits may have been subject to a manufacturing error where some containers were under-filled and topped up with the incorrect reagent, leading to inadequate staining. if the product is used according to the instructions for use with the adequate controls, the end user would be able to identify the test has not stained correctly.
  • Action
    Leica Biosystems is advising users to discontinue use of the affected lot numbers and destroy any remaining stock. Leica Biosystems is recommending consulting with the Laboratory Director and Physician to determine if a review of past results is warranted. This action has been closed-out on 29/08/2016.

Device

Polymer Refine Red Detection (used for testing and identification of neoplasm). An in vitro diagn...
  • Model / Serial
    Polymer Refine Red Detection (used for testing and identification of neoplasm). An in vitro diagnostic medical device (IVD)Product Code: DS9390Lot Number: 41872 Expiry date: November 2016ARTG Number: 211376
  • Manufacturer
    Leica Biosystems Melbourne Pty Ltd

Manufacturer

Leica Biosystems Melbourne Pty Ltd