Events

Recall of Biomerieux BacT/ALERT System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by BioMerieux Inc.

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
    13674
  • Event Initiated Date
    2012-10-24
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: BioMerieux New Zealand Ltd, Suite 4, The Business Connection Office, 2 Kalmia Street, Auckland 1544
  • Reason
    Bact/alert instrument software architecture is linearly designed to scan, proces and load one bottle at a time., manufacturer recently launched the new bact/alert 3d b.40.Xx firmware that contains additional features such as bottle recalculation and bottle authentication. as a result of the additional features customers with control modules containing lbc-586 cpus, distributed from 1997 through november 2007, and running b.40 firmware may exhibit a slightly slower instrument interface issue that may result in bottles being improperly loaded into the instrument.
  • Action
    Instructions for use to be updated

Device

Biomerieux BacT/ALERT System
  • Model / Serial
    Model: 411814 or 411818, Affected: Firmware version B.40.xx
  • Manufacturer
    BioMerieux Inc

Manufacturer

BioMerieux Inc