Events

Recall of UNICEL DXH SLIDEMAKER STAINER

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
    17428
  • Event Risk Class
    II
  • Event Initiated Date
    2017-06-21
  • 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 a fitting installed in a select population of slidemaker stainer (sms) units may not completely seal after being installed. not all fittings installed may be affected. for those affected one may observe a slow dripping leak of the staining reagents (methanol alcohol and buffers) into the spill tray below designed for this purpose.

Device

UNICEL DXH SLIDEMAKER STAINER
  • Model / Serial
    Model Catalog: 775222 (Lot serial: SW VERSION 3.2)
  • Product Description
    UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.