Events

Safety Alert for UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Beckman Coulter.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-08-11
  • Event Date Posted
    2016-08-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_201608011.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: beckman coulter unicel dxh slidemaker stainer coulter cellular analysis system medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its unicel dxh slidemaker stainer coulter cellular analysis system [part number reference 775222; all software revisions]. the manufacturer 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. the manufacturer is investigating the reported incident to determine the root cause, and define and implement required corrective and preventive actions. the manufacturer is advising users to: immediately discontinue use of the stainer module; drain all liquids from the stainer module; follow the directions provided for placing the stainer module in extended shutdown and disabling the stainer.; and a manufacturer’s 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. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 august 2016.

Device

UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Beckman Coulter UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter