Events

Recall of VITEK 2 System version 7.01. An in vitro diagnostic medical device (IVD).Bacteria identification and sensitivity system

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-2015-RN-00096-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-02-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00096-1
  • 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
    Biomeriuex has identified that the inoculum density range for the neisseria haemophilus (nh) identification (id) test card in the vitek 2 7.01 product information document (ref: 514740-1en1) is incorrect. in section 6 - procedure for nh card specimen preparation (step 3), the documented densichek plus inoculum density range is 1.80 - 2.20. the correct density range is 2.70 - 3.30.The incorrect information is located on the dvd software for the vitek 2 7.01 system. all other product documentation has the correct inoculum density.
  • Action
    bioMerieux is advising end users of the incorrect inoculum density range and requesting that the recall letter be kept with the instrument documentation. bioMerieux will update the VITEK 2 7.01 Product Information to include the correct DensiCHEK inoculation concentration. This action has been closed-out on 09/08/2016.

Device

VITEK 2 System version 7.01. An in vitro diagnostic medical device (IVD).Bacteria identification ...
  • Model / Serial
    VITEK 2 System version 7.01. An in vitro diagnostic medical device (IVD).Bacteria identification and sensitivity system
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd