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
    77069
  • Event Risk Class
    III
  • Event Initiated Date
    2016-04-05
  • 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
    The dxh 800 dxh 600 and dxh slidemaker stainer may fail to notify the user of warnings or error conditions for low or depleted reagent conditions daily checks failures lis disconnection and printer failures at: - the alert status icon(s) on the system manager - the audible alarm at the system manager - the instrument beacon on the specimen processing module or slidemaker stainer the failure may occur when the system manager application is restarted or powered off/on.

Device

UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
  • Model / Serial
    Model Catalog: B24802 (Lot serial: All); Model Catalog: 629029 (Lot serial: All); Model Catalog: 775222 (Lot serial: All); Model Catalog: B23858 (Lot serial: All)
  • Product Description
    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM;UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM;UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.