Events

Recall of Novocastra Lyophilised Mouse Monoclonal Antibody CD10 Reagents. 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-00892-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-09-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00892-1
  • 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 novocastra lyophilised mouse monoclonal antibody cd10 reagent lots do 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, which may result in inadequate staining and lead to weak or false negative pathology results. this could potentially result in misclassification of a neoplasm and inappropriate management.
  • Action
    Leica Biosystems is advising users to cease use and destroy any remaining stocks of affected product. A review of previously obtained results is recommended at the discretion of the laboratory director and physician. This action has been closed-out on 03/03/2017.

Device

Novocastra Lyophilised Mouse Monoclonal Antibody CD10 Reagents. An in vitro diagnostic medical de...

Manufacturer

Leica Microsystems Pty Ltd