Events

Recall of BBL Crystal Enteric/Nonfermenter 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-2014-RN-00599-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-05-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00599-1
  • 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 has determined that the crystal inoculum fluid within the bbl crystal enteric/nonfermentor (e/nf) identification kits from the referenced lots are labelled with incorrect expiration dates. the crystal inoculum fluid bottles expire prior to the date that was printed on the kit carton. the expiration date printed on the individual crystal inoculum fluid bottles is correct.
  • Action
    BD is requesting their customers to discard the outer boxes that are labelled with the incorrect expiration date.

Device

BBL Crystal Enteric/Nonfermenter ID Kit. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    BBL Crystal Enteric/Nonfermenter ID Kit. An in vitro diagnostic medical device (IVD).Catalogue Number: 245000Lot Numbers: 3224281 & 3290379ARTG Number: 195682
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd