Events

Recall of VITEK MS, firmware version 3.10 and 3.13 (bacterial and fungal identification system which uses the matrix-assisted laser desorption / ionization (MALDI) mass spectrometry method) (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-2013-RN-01051-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01051-1
  • 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
    Some issues have been reported when firmware version 3.13 was installed on systems equipped with the old transient recorder (tr) board (ref. 6200350). extensive testing has proven that firmware 3.13 may potentially cause an instrument to freeze or hang during acquisition when installed with the old tr board, with a risk of repeated results for different spots. this issue does not occur if firmware version 3.13 is installed with the new tr board ae8679ad (ref. 6200720).
  • Action
    Biomerieux is requesting users to reboot the instrument if the board freezes. Biomerieux is advising users that the new TR board is required to have firmware V3.13, and the old TR board is required to have firmware version V3.10. Biomerieux is contacting users to migrate the firmware if required.

Device

VITEK MS, firmware version 3.10 and 3.13 (bacterial and fungal identification system which uses t...
  • Model / Serial
    VITEK MS, firmware version 3.10 and 3.13 (bacterial and fungal identification system which uses the matrix-assisted laser desorption / ionization (MALDI) mass spectrometry method) (an in vitro diagnostic medical device (IVD))Catalogue Number: 410895Serial Numbers: Lower than #50039, #50050, greater than or equal to #60000ARTG Number: 199422
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd