Events

Recall of Unicel DxH Slidemaker Stainer Coulter Cellular Analysis 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-2017-RN-00808-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-06-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00808-1
  • 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 determined that a fitting installed in a select population of slidemaker stainer (sms) units may not completely seal after being installed. please note that not all fittings installed may be affected. for those affected, one may observe a slow dripping leak of the staining reagents (methanol, alcohol and buffers) into the spill tray below designed for this purpose. there is no impact to patient results due to this issue. there is no new or additional safety risk associated with this issue beyond the continued potential of exposure to stain and methanol associated with the handling of these chemicals resulting from a slow dripping leak.
  • Action
    Beckman Coulter is asking that customers: 1 - Immediately contact your Beckman Coulter representative to schedule a service visit in the event of a leak. Beckman Coulter Field Service Engineers will replace the fitting on the impacted instruments. 2 - Inspect the reagent supply drawer for spills; if necessary, clean up with absorbent materials such as paper towels, and dispose in accordance with your local regulations and laboratory procedures. 3 - Follow best laboratory practices when using the instrument, which includes the use of appropriate personal protective equipment (PPE) to protect the user from exposure.

Device

Unicel DxH Slidemaker Stainer Coulter Cellular Analysis System. An in vitro diagnostic medical de...
  • Model / Serial
    Unicel DxH Slidemaker Stainer Coulter Cellular Analysis System. An in vitro diagnostic medical device (IVD)Software version 3.2Part Number: PN 775222ARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd