Events

Recall of Bartels Herpes Simplex Virus Fluorescent Monoclonal Antibody Test. 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 Immuno 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-00742-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-07-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00742-1
  • 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
    As a result of an internal investigation by trinity biotech, it has been determined that the symbol to denote 'harmful' has been omitted from the package insert. the information within the package insert regarding tha handling and disposal of the product is still correct. if the package insert and msds is followed correctly there is no risk to the end user when handling or disposing of the kits.
  • Action
    Immuno is advising their customer that the product was supplied without the appropriate symbol to denote "Harmful". End users should be aware that all the information within the package insert is correct including handling and disposal instructions.

Device

Bartels Herpes Simplex Virus Fluorescent Monoclonal Antibody Test. An in vitro diagnostic medical...
  • Model / Serial
    Bartels Herpes Simplex Virus Fluorescent Monoclonal Antibody Test. An in vitro diagnostic medical device (IVD).Product code: B1029-47Lot number: C091009Expiry date: 17 March 2015
  • Manufacturer
    Immuno Pty Ltd

Manufacturer

Immuno Pty Ltd
  • Source
    DHTGA