Events

Recall of Novocastra Liquid Mouse Monoclonal Antibody. 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-00028-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-01-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00028-1
  • 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 product listed above does not function as intended up to the expiry date on the product labelling. there is a link between the age of the product and staining intensity. there is a remote risk of a patient being diagnosed with incorrect tumour based on a false negative cd15 staining result.
  • Action
    Leica Biosystems is advising users to destroy any remaining unused stock. 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. If this is not the case, clinicians may wish to review results obtained with the affected lot.

Device

Novocastra Liquid Mouse Monoclonal Antibody. An in vitro diagnostic medical device (IVD)

Manufacturer

Leica Biosystems Melbourne Pty Ltd