Events

Recall of BacT/ALERT PF Plus Culture Bottle. 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-00913-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-08-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00913-1
  • 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
    Bact/alert pf plus culture bottle, lot 1033298, yielded reflectance results above the stability specification at the 9-month time frame. bottles that have reflectance results near or greater than the initial value threshold specification when first loaded on the instrument could have an increased probability of false positive results.
  • Action
    Bio Merieux is requesting their customers to discontinue use of the affected batch remaining in stock. Bottles that are already inoculated or incubating should be allowed to complete their testing/incubation. All bottles flagged positive by the instrument should continue to be treated as stated in the instructions for use.

Device

BacT/ALERT PF Plus Culture Bottle. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    BacT/ALERT PF Plus Culture Bottle. An in vitro diagnostic medical device (IVD)Catalogue Number: 410853Lot Number: 1033298Expiration Date: 16 October 2013
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd