Events

Recall of BacT/ALERT 3D B.40.xx Firmware (Automated blood culture incubator/growth detector). 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-2012-RN-01071-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-10-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01071-1
  • 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
    An improper load occurs when the user performs another action (such as loading a bottle or scanning another bottle) before the reply beeps have been issued. an improper load results in the first bottle not being recognised as being loaded in the instrument and the second bottle's readings being incorrectly reported in association with the first bottle.
  • Action
    Affected laboratories are to implement the corrected User Manual provided by the Sponsor.

Device

BacT/ALERT 3D B.40.xx Firmware (Automated blood culture incubator/growth detector). An in vitro d...
  • Model / Serial
    BacT/ALERT 3D B.40.xx Firmware (Automated blood culture incubator/growth detector). An in vitro diagnostic medical device (IVD)Product code: 411814 or 411818
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd