Events

Recall of ARGENE Adenovirus R-gene and Parechovirus R- Gene Control Kits. (An in vitro diagnostic medical device)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Biomerieux Australia 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-2018-RN-00143-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-02-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00143-1
  • 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
    It has been identified that a proportion of kits in the argene range have been mislabelled, where the target name is missing from the tube label. the kits are colour coded by reference to minimise the risk of mixing tubes from different references.
  • Action
    BioMerieux is advising users that the affected product can continue to be used. Users are reminded that the affected products are colour coded by reference, and include the reference number on the labelling.

Device

ARGENE Adenovirus R-gene and Parechovirus R- Gene Control Kits. (An in vitro diagnostic medical d...
  • Model / Serial
    ARGENE Adenovirus R-gene and Parechovirus R- Gene Control Kits. (An in vitro diagnostic medical device)Adenovirus R-gene Quantification Standard (QS) and Sensitivity Control (SC)Refernece Number: 69-010BLot Number: 1005056960Expiry date: 25/08/2018Parechovirus R-gene Postive control (PC20)Reference Number: 71-020Lot Number: 1005090480Expiry Date: 31/08/2018ARTG Number: 211361 (Biomerieux Australia - Viral infectious disease IVDs)
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd