Events

Recall of BacT/ALERT BPN Culture Bottles. 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-2017-RN-00794-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-06-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00794-1
  • 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
    Biomérieux has become aware of a crimp defect associated with the bact/alert bpn culture bottles. an anomaly was identified during the manufacturing process that may lead to having excess material at the neck of the bottle. this material may separate from the crimp exposing a sharp edge or causing a minor cut hazard.
  • Action
    Customers are requested to: - Confirm this letter has been distributed to and reviewed by all appropriate personnel within the organisation. - Review inventory of BacT/ALERT BPN bottles for Lot Number 1048256 and discard all affected bottles from this lot. Please store this letter with your bioMerieux instrument documentation.

Device

BacT/ALERT BPN Culture Bottles. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    BacT/ALERT BPN Culture Bottles. An in vitro diagnostic medical device (IVD)Reference Number: 279045Lot Number: 1048256ARTG Number: 194228
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd