Events

Recall of BBL Crystal Enteric/Non-fermenter ID Kit, 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-2013-RN-00004-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-01-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00004-1
  • 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
    Becton dickinson has determined that these products have the citrate (cit) and malonic acid (mlo) reagents in the reversed prong/well positions. this may lead to no-identification or multiple identification choices. customers specifically reported split identification results between citrobacter and salmonella, however other bacterial identifications requiring the use of these two substrates may be affected.
  • Action
    Becton Dickinson Pty Ltd is advising customers to discontinue use and discard any affected product. Replacement product or credit will be provided for any discarded product.

Device

BBL Crystal Enteric/Non-fermenter ID Kit, An in vitro diagnostic medical device (IVD)
  • Model / Serial
    BBL Crystal Enteric/Non-fermenter ID Kit, An in vitro diagnostic medical device (IVD)Catalogue number: 245000Lot number: 2129487Expiration date: 13 March 2013
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd