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
    53235
  • Event Risk Class
    II
  • Event Initiated Date
    2011-04-15
  • 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 the following issues with the unicel dxh 800 coulter cellular analysis system: 1.Auto prune will not remove patient results if the patient record includes demographics where the results are less than 30 days old. 2.The last set of results for each panel analyzed without demographics will always be saved. 3.The dxh 800 may intermittently fail to transmit the correct control files or partially transmit the number of control files requested to the interlaboratory quality assurance program ("iqap") through the remote management system (rms). 4.The dxh 800 exports control data intended for interlaboratory quality assurance (iqap) in the reporting units configured by the customer. iqap is expecting to receive those results in one standard format.

Device

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

Manufacturer

BECKMAN COULTER CANADA L.P.