Events

Recall of NCL-L-CD15. An in vitro diagnostic medical device (IVD).(NovocastraT Liquid Mouse Monoclonal Antibody)

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-01357-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-12-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01357-1
  • 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. no customer complaints relating to this issue have been received. there is the potential risk of a patient being diagnosed with incorrect tumor based on a false negative cd15 staining result. delay in diagnosis/ misdiagnosis of a patient with hodgkin’s disease. positive control tissue would show weaker than expected or negative staining. an unexpected result would be highlighted by the use of appropriate controls. additionally, if a pathologist did not follow standard medical practice there could be a possibility that an incorrect or delayed diagnosis could result and appropriate treatment for the patient could be delayed. this could possibly result in improper staging of the patient’s disease or resulting in the patient’s death.
  • Action
    End users are requested to discard any remaining product from the affected lot and contact their Leica representative immediately if a replacement is required.

Device

NCL-L-CD15. An in vitro diagnostic medical device (IVD).(NovocastraT Liquid Mouse Monoclonal Anti...

Manufacturer

Leica Biosystems Melbourne Pty Ltd