Events

Recall of Novocastra Liquid Mouse Monoclonal Antibody Calretinin. 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-2016-RN-00563-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00563-1
  • 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
    In the event that the product is used with diluents other than those listed, it may not provide adequate staining. when used according to the instructions for use with appropriate positive controls, the failure to adequately stain would be apparent to the user on the control tissue and on the patient tissue. in these instances, the absence of adequate staining of tissue is likely to result in a delay in obtaining the results of ihc / ish staining and, in a worst-case scenario, could cause a delay in the diagnosis or classification of a neoplasm.
  • Action
    Leica is advising users to only use Novocastra Liquid Mouse Monoclonal Antibody Calretinin with the specified diluents. There is no need for retrospective review of tissue staining if appropriate positive controls were properly used and interpreted during the immuno / in situ staining. This action has been closed-out on 25/01/2017.

Device

Novocastra Liquid Mouse Monoclonal Antibody Calretinin. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Novocastra Liquid Mouse Monoclonal Antibody Calretinin. An in vitro diagnostic medical device (IVD)Product Code: 1ml NCL-L-CALRET-566Lot Numbers: 6025204, 6029060, 6036060Only to be used in combination with:Diluent Lot NumbersAR9352 SLBL4196V, SLBL8154V, SLBM1997V, SLBM3199VAR9352-CN SLBL8154V SLBM1997VRE7133-CE 6035000RE7133-CN 6035115ARTG Number: 178442
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd