Events

Recall of BK Virus R-gene kit when used on SmartCycler 2.0 platform. 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 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-2017-RN-00141-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00141-1
  • 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
    Following a customer complaint and an internal investigation, biomérieux has confirmed that when testing weak viral load samples, in conjunction with bk virus r-gene kit on smartcycler 2.0 platform, negative results may be obtained instead of positive as expected. the investigation confirmed that the issue has been observed only with smartcycler 2.0 and the issue only concerns low viral load samples (viral load equal or below the sensitivity control). the issue is detected by the sensitivity control (sc) that is the equivalent of a weak positive sample, which will be systematically negative instead of positive in most of the cases. when no sensitivity control is systematically run, there is a potential risk to obtain a false negative result. based on the investigation data, the performances claimed in the ifu regarding the use of smartcycler 2.0 in conjunction with bk virus r-gene kit could not be warranted.
  • Action
    bioMérieux is advising customers to stop using the BK Virus R-gene kit ref. 69-013B on Smart Cycler 2.0. It is recommended that any concern customers have regarding previously reported results is discussed with the Laboratory Medical Director to determine the appropriate course of action.

Device

BK Virus R-gene kit when used on SmartCycler 2.0 platform. An in vitro diagnostic medical device ...
  • Model / Serial
    BK Virus R-gene kit when used on SmartCycler 2.0 platform. An in vitro diagnostic medical device (IVD).(used for measuring the viral load of BK virus in whole blood, plasma and urine samples)Catalogue Number: 69-013BARTG Number: 211361
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd