Events

Recall of UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System

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-01049-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-08-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01049-1
  • 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 received and confirmed a report of a fire within the stainer module of a customer’s dxh slidemaker stainer. the fire was fully contained within the stainer module. the event was preceded by a significant increase in the frequency of the automatic top-off of the module’s methanol bath. users are being advised to discontinue use of the stainer module to reduce the potential for flammable liquids coming into contact with electrical components in the stainer module possibly causing a fire. beckman coulter is actively investigating the reported incident to determine the root cause, and define and implement required corrective and preventive actions.
  • Action
    Beckman Coulter is advising users to: 1. Immediately discontinue use of the Stainer module. 2. Drain all liquids from the Stainer module. 3. Follow the directions provided for placing the Stainer module in extended shutdown and disabling the Stainer. Once the Stainer has been disabled, the Slidemaker module may be used to prepare slides for staining. Slides must be stained using an alternative method. A Beckman Coulter service representative will schedule a visit to modify the Stainer module so that it remains disabled and cannot be used until further corrective action is implemented. This action has been closed-out on 02/03/2017.

Device

UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System

Manufacturer

Beckman Coulter Australia Pty Ltd