Events

Recall of Hettich Centrifuge Bucket Model 4464-R. An in vitro diagnostic medical device (IVD)(used on StreamLAB Centrifuges, Aptio Centrifuges, FlexLab High Throughput Centrifuges and FlexLab)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare 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-00663-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-05-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00663-1
  • 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
    Siemens healthcare diagnostics is issuing an urgent recall for product correction notice for the hettich centrifuge buckets (model 4464-r) of affected hettich rotanta 46 rsc robotic and rotanta 460 robotic centrifuges. hettich, the centrifuge manufacturer is currently investigating the reason for premature bucket failures. there is the possibility that material changes may have an impact of the strength of the buckets. when the hettich centrifuge bucket fails during centrifugation, the potential exists for a delay in patient testing and the potential for movement/rotation of the centrifuge.
  • Action
    Siemens is providing users with instructions to conduct a weekly check of centrifuge buckets for signs of cracking and replace if required. Additionally, the maximum RPM should be reduced to 3,500 rpm.

Device

Hettich Centrifuge Bucket Model 4464-R. An in vitro diagnostic medical device (IVD)(used on Strea...
  • Model / Serial
    Hettich Centrifuge Bucket Model 4464-R. An in vitro diagnostic medical device (IVD)(used on StreamLAB Centrifuges, Aptio Centrifuges, FlexLab High Throughput Centrifuges and FlexLab)Model Number: 4464-RMultiple model numbers of affected centrifuges ARTG Numbers: 174699, 238361
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA