Events

Recall of UniCel DxC Synchron Systems No Foam Reagent (used with the UniCel DxC Synchron Clinical System). 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-2016-RN-00900-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00900-1
  • 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 an incompatibility between no foam dxc reagent (ref b64130) and the dxc hydropneumatic parts associated with no foam delivery. dxc no foam reagent is intended to prevent formation of foam and/or bubbles in the dxc waste system of the hydropneumatic subsystems. over time, this incompatibility may lead to:- breaks in no foam cap assembly- cracks in no foam waste collector; and- seepage outside no foam tubingthis incompatibility does not affect no foam’s ability to perform its function and there is no impact to patient results. however, this issue may lead to cracks in the waste collector which may stop instrument operation due to vacuum error, and potentially lead to biohazardous waste exposure. this may lead to a delay in patient results. cracks in the no foam cap and seepage from the no foam tubing may lead to exposure to no foam. there have been no reports of injuries as a result of this issue.
  • Action
    Beckman Coulter is advising users to continue to use No Foam (Ref: B64130) until a replacement No Foam (Ref; 469110) has been received. Once the replacement No Foam has been received, remaining stocks of No Foam (Ref: B64130) should be discarded.

Device

UniCel DxC Synchron Systems No Foam Reagent (used with the UniCel DxC Synchron Clinical System). ...
  • Model / Serial
    UniCel DxC Synchron Systems No Foam Reagent (used with the UniCel DxC Synchron Clinical System). An in vitro diagnostic medical device (IVD) Reference Number: B64130ARTG Number: 229315
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd