Events

Recall of COULTER GEN*S SLIDESTAINER

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
    80092
  • Event Risk Class
    III
  • Event Initiated Date
    2013-02-27
  • 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
    Some bottles of the 2 liter bottle primary label of coulter trucolor wright giemsa stain lot 0640688 were incorrectly labeled as coulter trucolor may-grunwald stain. the secondary package (outside box) however is correctly labeled as wright giemsa stain.

Device

COULTER GEN*S SLIDESTAINER
  • Model / Serial
    Model Catalog: 7547178 (Lot serial: 0640688)
  • Product Description
    COULTER TRUCOLOR WRIGHT GIEMSA STAIN
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.