Events

Recall of BD Vacutainer CPT Cell Preparation Tube. 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-00704-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00704-1
  • 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 is conducting a recall of the above mentioned blood collection tube due to poor separation resulting in a reduced number of recovered mononuclear cells. having an insufficient number of isolated mononuclear cells may lead to possible specimen recollection, potential delay of treatment, and in remote cases, could lead to erroneous results.
  • Action
    BD is requesting their customers to check their inventory and quarantine product subject to this recall. BD will arrange for the collection and replacement of all affected stock.

Device

BD Vacutainer CPT Cell Preparation Tube. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    BD Vacutainer CPT Cell Preparation Tube. An in vitro diagnostic medical device (IVD).Catalogue Number: 362761Lot Numbers: 4063411 & 4090230ARTG Number: 177829
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd