Events

Recall of UNICEL DXH 600 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
    111649
  • Event Risk Class
    II
  • Event Initiated Date
    2015-12-01
  • 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 determined that the affected software for the dxh systems allows the creation of multiple orders with the same specimen identification (id) but different patient identification when manually editing pending orders at the system manager. the issue does not occur for edits of relased results or for test orders requested through host transmission. the issue creates the potential for sample misidentification and potential of releasing erroneous results.

Device

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

Manufacturer

BECKMAN COULTER CANADA L.P.