Events

Recall of BD MAX Instruments. 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-00582-2
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-06-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00582-2
  • 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 during instrument testing a small portion of instruments were built with the wrong power module component, which is rated 1 amp instead of the required 10 amp. bd has advised that the user would not be aware of this defect, as the instrument will function as expected, with no impact on specimen processing or results reporting. however, the component inside the instrument will get hot, and over time the component will fail, which could cause downtime and require a service visit.The bd max instrument operates with a current between 1.3 and 3 amps. in assessing the potential impact of installing a 1 versus 10 amp power input module, the manufacturer ran the 1 amp power input module at various current levels and measured the temperature of the component, with the following results:1.9 a for 14 minutes – 45°c3.3 a for 20 minutes – 66°c4.4 a for 14 minutes – 80°c. the component is rated by its manufacturer for use up to 85°c.
  • Action
    A BD service representative will correct affected systems on-site after undertaking a system check to determine if there are any affected systems in the field.

Device

BD MAX Instruments. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    BD MAX Instruments. An in vitro diagnostic medical device (IVD)Catalogue number: 441916Serial numbers: CT0182, CT0213 & CT0174
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd