Events

Recall of Arthrex and Andreas Hettich Rotofix 32A 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 Device Technologies 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-2012-RN-00929-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2012-09-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00929-1
  • 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
    It has been identified that affected serial numbers may be able to be opened during centrifugation due to a manufacturing fault of the upper parts, resulting in affected units will have a higher bending edge (i.E. the hole for the emergency release pin is lower than it should be).
  • Action
    Customers to inspect all units as per the instructions provided in the recall notice and isolate any affected units. Sponsor will replace upper housing of affected centrifuges.

Device

Arthrex and Andreas Hettich Rotofix 32A Centrifuge, An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Arthrex and Andreas Hettich Rotofix 32A Centrifuge, An in vitro diagnostic medical device (IVD)Product Code: ABS-10020Serial numbers: 14843 to 15070 and 15360 to 15559
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd