Events

Recall of UniCel DxI 800 Access Immunoassay Systems, Unicel DxI 600 Access Immunoassay Systems, UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical System. In vitro diagnostic medical devices (IVDs)

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-2013-RN-00107-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-02-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00107-1
  • 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
    Improper tubing installing by the customer during routine maintenance may prevent the dxi and dxc systems from washing reaction vessels properly and may lead to erroneous test results. the reason for the customer mis-routing of instrument tubing was determined to be two fold:- the mechanical controls on the instrument were insufficient to prevent incorrect routing of the aspirate and dispense tubing.- the instructional drawings in the service documentation were difficult for the customer to understand.This recall action was not notified to the tga before it was initiated by beckman coulter australia.
  • Action
    Beckman Coulter Australia is advising that all affected systems were corrected with a new design that provided mechanical controls to reduce the potential for tubing installation errors. Also, updated service documentation with clearer instructions were distributed to affected customers.

Device

UniCel DxI 800 Access Immunoassay Systems, Unicel DxI 600 Access Immunoassay Systems, UniCel DxC ...
  • Model / Serial
    UniCel DxI 800 Access Immunoassay Systems, Unicel DxI 600 Access Immunoassay Systems, UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical System. In vitro diagnostic medical devices (IVDs)Part numbers: 973100, A30260, A71456, A71457, A71460, A71461, A25285, A25288, A92060
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd