Events

Recall of COULTER LH SLIDESTAINER/SLIDEMAKER

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
    71298
  • Event Risk Class
    II
  • Event Initiated Date
    2012-02-21
  • 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
    Customers have reported stain fading and difficulty with cell and morphology identification after the stain has been onboard in the stain baths for more than two hours. -cells and their morphology may be difficult to identify. -there is a remote probability of a delay in delivery of patient results due to the lack of availability of a properly stained blood film for a leukocyte differential.

Device

COULTER LH SLIDESTAINER/SLIDEMAKER
  • Model / Serial
    Model Catalog: 6605645 (Lot serial: 626171); Model Catalog: 6605645 (Lot serial: 624776)
  • Product Description
    TruColor Giemsa Stain and TruColor May-Grunwald Stain
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.