Events

Recall of BD Stem Cell Control Kit (used with BD FACSCanto flow cytometers). 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-00632-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-06-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00632-1
  • 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 become aware that some of the affected units are unable to be used for optimisation of bd facscanto flow cytometers when performing the bd stem cell enumeration assay. in that case the user will not be able to continue to run the bd stem cell enumeration assay.As the optimisation setup is manual on the bd facscalibur flow cytometer, this potential issue does not arise when using this system.
  • Action
    BD is requesting their customers to discard any affected lots of the Stem Cell Control Kit.

Device

BD Stem Cell Control Kit (used with BD FACSCanto flow cytometers). An in vitro diagnostic medical...
  • Model / Serial
    BD Stem Cell Control Kit (used with BD FACSCanto flow cytometers). An in vitro diagnostic medical device (IVD)Catalogue number: 340991Lot numbers: BC053 & BC063Expiration dates: 2013-06-02 & 2013-07-02ARTG number: 197669
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd