Events

Recall of BBL DrySlide Oxidase 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-00368-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00368-1
  • 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 confirmed through complaint investigation that during the manufacturing process portions of the affected test slides were placed into the incorrect packaging.
  • Action
    BD is asking users to destroy the affected units.

Device

BBL DrySlide Oxidase Kit. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    BBL DrySlide Oxidase Kit. An in vitro diagnostic medical device (IVD)Catalogue Number: 231746Lot Number: 2222008Expiration Date: 31 August 2013
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd