Events

Recall of Automated 2500 Family Systems

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Beckman Coulter Australia 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-2018-RN-00079-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-02-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00079-1
  • 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
    Beckman coulter has identified a potential issue, where belts on the x-axis (and on the y-axis, to a lesser extent) are showing premature failure and breaking.
  • Action
    Beckman Coulter will be in contact with affected users to arrange replacement of the affected belts by a service technician.

Device

Automated 2500 Family Systems
  • Model / Serial
    Automated 2500 Family SystemsModels: ODL25120 AutoMate 1200ODL25125 AutoMate 1250ODL25250 AutoMate 2500ODL25255 AutoMate 2550ARTG: 177999 (Beckman Coulter Australia Pty Ltd - Instrument/analyser IVDs)
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd