Events

Recall of Rotor Yokes (used in Allegra X-5 Centrifuge). 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 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-2016-RN-00174-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-02-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00174-1
  • 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
    A defective rotor yoke allows improper rotor seating on the hub resulting in possible rotor failure if the buckets are loaded in an imbalanced configuration.If the rotor becomes unbalanced it may vibrate excessively and/or exhibit smoke if the rotor is rubbing inside the centrifuge.There is a chance of physical injury to users as a result of the vibration if the issue occurs. there is also a remote risk of a delay in results if the failure occurs.
  • Action
    Beckman Coulter is replacing the affected rotor yokes. The centrifuge can continue to be used, as long as all runs are balanced appropriately.

Device

Rotor Yokes (used in Allegra X-5 Centrifuge). An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Rotor Yokes (used in Allegra X-5 Centrifuge). An in vitro diagnostic medical device (IVD)Rotor Yokes Part Number: B30593Lot Numbers: 322/13 and 355/13ARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd