Events

Recall of UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECKMAN COULTER CANADA L.P..

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
    21768
  • Event Risk Class
    III
  • Event Initiated Date
    2013-07-31
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Beckman coulter has identified an issue regarding the response speed on the dxh system manager for unicel dxh 800 and 600 coulter cellular analysis systems that are connected to the proservice remote management system (rms). systems connected to the proservice remote management system (rms) that have not been rebooted after processing approximately 2000 patient samples will slow down and eventually terminate processes. patient results are not affected by this issue.

Device

UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
  • Model / Serial
    Model Catalog: 629029 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: B23858 (Lot serial: ALL SERIAL NUMBERS)
  • Product Description
    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.