Events

Recall of VIDAS and mini VIDAS systemsIn vitro diagnostic medical devicesIn combination with Quality Control VIDAS (QCV)

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-00060-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00060-1
  • 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
    A review of relevant data and feedback from users has identified there are some pump clogging and displacement of the colour coded label. the pump clogging could contribute to erroneous results for any assay performed on the vidas and mini vidas system due to decrease of pipetted volume.
  • Action
    bioMérieux is advising users to implement the following permanent changes in managing the affected systems: 1. Increase the frequency of the QCV testing to weekly rather than monthly to reduce the period of potential retrospective analyses needed. In the event of QCV test fail, it is recommended to review previous results with the laboratory medical director, and perform a retrospective analysis of all patient specimens processed since the last successful QCV test. bioMérieux will update the User Manual to reflect this requirement 2. As indicated within the Instructions For Use, continue to conduct a visual inspection of the SPR after each run (including patient sample test and QCV test) to ensure that the dot on the SPR is still in place In response, bioMérieux is taking action to help ensure the instruments perform as intended: 1. Pumps have to be changed every 7 years 2. bioMérieux will systematically clean the VIDAS/mini VIDAS pumps during the yearly Preventive Maintenance

Device

VIDAS and mini VIDAS systemsIn vitro diagnostic medical devicesIn combination with Quality Contro...
  • Model / Serial
    VIDAS and mini VIDAS systemsIn vitro diagnostic medical devicesIn combination with Quality Control VIDAS (QCV) (ARTG: 203664)Multiple Affected Reference NumbersARTG Number: 199422 Biomerieux Australia Pty Ltd - Instrument/analyser IVDs
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd