Events

Recall of Ki67-MM1 Bond Ready To Use, 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 Microsystems 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-00344-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-04-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00344-1
  • 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 lot numbers do not consistently perform as expected and in some instances have exhibited weaker than expected staining. a false negative result could potentially result in the underestimation of the aggressiveness of a neoplasm, the mis-classification of a neoplasm, or failure to distinguish a benign process from a malignant one. any of these could result in the application of inappropriate treatment or delay in therapy. laboratories that follow procedures outlined in the products’ instructions for use (ifu) would identify the weak staining or negative staining in the tissue control.
  • Action
    Leica Biosystems is advising the users to return any unused product for a credit note. Leica Biosystems is advising users that clinical interpretation of staining or its absence should be evaluated within the context of the patient's clinical history and other diagnostic tests . A review of patient results may be warranted at the discretion of the pathologist. This action ha been closed-out on 31/08/2016.

Device

Ki67-MM1 Bond Ready To Use, An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Ki67-MM1 Bond Ready To Use, An in vitro diagnostic medical device (IVD)Product Code: PA0118Lot number: 28251Expiry Date: September 2017Lot number: 29784Expiry Date: January 2018Lot number: 29879Expiry Date: January 2018Lot number: 29880Expiry Date: January 2018Manufactured between September 2014 and January 2015.ARTG Number: 178442
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd