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
  • Event ID
  • Event Risk Class
    Class II
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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.


  • 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