Events

Recall of BD Epicenter v6.20A (used in conjunction with Bruker MALDI BioTyper) 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 Becton Dickinson 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-2014-RN-00883-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-08-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00883-1
  • 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
    Bd epicenter allows for the integration of bd phoenix drug susceptibility results with bruker's maldi biotyper organism identification results within a single id/ast workflow.Bruker updated the maldi biotyper msp database where organism naming changes have been implemented. bd, unaware of these changes, did not implement corresponding changes to the bd epicenter database. this could lead to inconsistency of the orgnaism name between the bd epicenter and bruker maldi biotyper for a limited number of organisms.Bd has performed an analysis of the changes and determined that these inconsistencies either have no relevance to human care (relevant only to plant or animal infection) or have limited impact to human care due to no claims for id or ast in the bd phoenix system.
  • Action
    BD has developed a tool that will update the relevant data to ensure consistency between the MALDI BioTyper and BD EpiCenter systems after a Bruker MSP database change. This tool will be run by a BD Technical Service representative or can be applied through a remote connection. This action has been closed-out on 01/03/2016.

Device

BD Epicenter v6.20A (used in conjunction with Bruker MALDI BioTyper) An in vitro diagnostic medic...
  • Model / Serial
    BD Epicenter v6.20A (used in conjunction with Bruker MALDI BioTyper) An in vitro diagnostic medical device (IVD)Reference number: 441007ARTG number: 222680
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd