Events

Recall of DXH 500

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
    145041
  • Event Risk Class
    II
  • Event Initiated Date
    2016-07-19
  • 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
    A specimen misidentification may occur despite an active software prompt on the screen when the following sequence of events occurs: - pending test orders exist on the worklist - a new specimen id is added using the "next" icon on the sample analysis - patient results screen or by scanning a specimen barcode label - the user leaves the screen before aspirating the new specimen upon returning to the sample analysis - patient results screen the following prompt displays "worklist contains entries. confirm next specimen id is correct before processing specimen" - the next specimen id field of the dxh 500 defaults to the first specimen id on the worklist which may not be the newest specimen identified - the issue occurs when the user fails to verify the specimen id the issue does not occur when the worklist has no pending test orders.

Device

DXH 500

Manufacturer

BECKMAN COULTER CANADA L.P.