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
    90502
  • Event Risk Class
    III
  • Event Initiated Date
    2014-03-18
  • 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 determined that when reporting units are not configured in us-1 and a delta check limit is set up using a difference value the unicel dxh 800 and unicel dxh 600 system manager may under or over generate delta check flags. the issue does not apply to delta checks configured using percent difference limits. delta checks performed at the laboratory information system (lis) are not affected. patient results are not affected.

Device

UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM
  • Model / Serial
    Model Catalog: B23858 (Lot serial: > 10 numbers contact mfg); Model Catalog: 629029 (Lot serial: > 10 numbers contact mfg); Model Catalog: B24802 (Lot serial: > 10 numbers contact mfg)
  • Product Description
    UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.