Events

Recall of VIDAS 3 System (used with software version 1.1.4) 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-00331-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-03-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00331-1
  • 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
    Software anomalies have been discovered in the vidas 3 software version 1.1.4. the following are the limitations that could impact the system:1. the “error code 0550capu1” posted in case of tip lost does not suggest the appropriate troubleshooting 2. for customers using automatic pipetting mode: non-justified “error code 0400fapu1”3. stop section during analytical phase can induce drop on the strip or into the instrument4. for customers managing their internal/external quality control via quality control module of vidas 3 only5. for countries applying winter time change only.
  • Action
    bioMérieux is advising users to apply the required actions associated with the relevant limitation (as described in the customer letter). Users are further advised to discuss concerns about previously reported results with their Laboratory Medical Director to determine the appropriate course of action.

Device

VIDAS 3 System (used with software version 1.1.4) An in vitro diagnostic medical device (IVD)
  • Model / Serial
    VIDAS 3 System (used with software version 1.1.4) An in vitro diagnostic medical device (IVD)Catalogue Number: 412590ARTG Number: 199422
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd