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
    23782
  • Event Risk Class
    III
  • Event Initiated Date
    2013-10-23
  • 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 confirmed slide staining irregularities being experienced by some customers using beckman coulter dxh and lh slides with coulter trucolor stains and buffers. customers have reported stain irregularities with the use of the slides stains and buffers listed aboveincluding: - red blood cells that appear hypochromic refractile or punched out. - excess precipitate that may be interpreted as increased cellular granularity in white blood cells inclusions in red blood cells and/or particles that interfere with platelet estimates. - a dark blue/purple background stain that may interfere with the ability to read the slides.

Device

UNICEL DXH SLIDEMAKER STAINER
  • Model / Serial
    Model Catalog: 775222 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 6605645 (Lot serial: ALL SERIAL NUMBERS)
  • Product Description
    UNICEL DXH SLIDEMAKER STAINER
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.