Events

Recall of Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel 600i Synchron Access Clinical System. In vitro diagnostic medical devices (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-2012-RN-01160-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-11-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01160-1
  • 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 problem in two pulley drive components in the mixer pulley assemblies of these systems.It has been determined that in some cases pulley drive components have broken parts or have become loose, mispositioned, or disconnected from their drive shafts. when these defects occur the pulley may not turn at all, or may turn at an incorrect speed, resulting in inadequate washing or mixing of the contents of the reaction vessel. beckman coulter is in the process of producing replacement components and will be installing them in every access/access 2 immunoassay, synchron lxi 725 clinical, and unicel dxc 6001 synchron access clinical system in the field.
  • Action
    Beckman Coulter is providing work around instructions to mitigate the risk and replacing the mixer pulley assemblies to permanently fix the problem.

Device

Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel ...
  • Model / Serial
    Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel 600i Synchron Access Clinical System. In vitro diagnostic medical devices (IVD)
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd