Events

Recall of BD MAX (6 channel) Instruments (Automated specimen preparation and PCR amplification/detection instrument). 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-2012-RN-00995-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-09-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00995-1
  • 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 bd max instrument may have minor defects that could cause the instrument to malfunction yet is unlikely to cause erroneous results. the minor defect(s) may be due to the following:1) a potential misalignment of the filters/lens in the reader assembly that can produce reaction curves with excess variability2) a supplier defect on a limited number of mux heater board assemblies.
  • Action
    Becton Dickinson Service Associate to inspect the instrument and perform corrections if required

Device

BD MAX (6 channel) Instruments (Automated specimen preparation and PCR amplification/detection in...
  • Model / Serial
    BD MAX (6 channel) Instruments (Automated specimen preparation and PCR amplification/detection instrument). An in-vitro diagnostic medical device (IVD)Catalogue Number: 441916Serial Numbers: CM0053 and CM0105
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd