Events

Recall of UniCel DxC ISE Reference reagent tubingUniCel DxC 600/800

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-2015-RN-00697-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00697-1
  • 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 failure of the unicel dxc ise tubing (lines 11, 25 and 26) for ise reference reagent. the failure occurs due to the interaction between a new tubing plasticiser and the ise reference reagent. the supplier's change in plasticiser was due to a move to a phthalate-free tubing material based on new environmental regulations. as a result, a visible slow-forming non-microbial white material may appear inside the tubing. this may result in suppressed ise quality control and patient results due to reference drift errors and/or ise calibration failures and/or tubing lines 25 or 26 detaching due to obstruction of flow.
  • Action
    Users are requested to immediately perform a visual inspection of ISE Reference reagent tubing 11, 25, and 26 for the white material and in cases where material is identified a workaround is provided. In the longer term, Beckman Coulter is qualifying new ISE tubing and laboratories will be notified when new tubing is available to be installed on instruments subject to this Recall. This action has been closed-out on 02/05/2017.

Device

UniCel DxC ISE Reference reagent tubingUniCel DxC 600/800

Manufacturer

Beckman Coulter Australia Pty Ltd