Events

Recall of Recapper for the AutoMate 2500 Family. 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-2017-RN-00748-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-06-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00748-1
  • 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 there is a potential that a component on the recapper module did not have the required coating specified for that part.The coating on the recapper component helps to ensure both the longevity of the part, and help the gripper to release the parafilm so it properly seals to the tube. if there is an uncoated component on your recapper, this could lead to the tubes not being properly sealed. in the worst case scenario, this could cause sample cross contamination and subsequent misdiagnosis.
  • Action
    Beckman Coulter will schedule a time to visit affected users to confirm whether the proper coating on the recapper component is present, and replace the component. In the interim, users are advised that no action is required on their part.

Device

Recapper for the AutoMate 2500 Family. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    Recapper for the AutoMate 2500 Family. An in vitro diagnostic medical device (IVD).ODL25250 AutoMate 2500ARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd