Events

Recall of COULTER ISOTON III DILUENT

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
    71444
  • Event Risk Class
    III
  • Event Initiated Date
    2014-04-25
  • 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 high platelet background counts during start up on coulter hmx analyzers with some containers of coulter isoton iii diluent lot 50752f. the issue was initially reported by a laboratory in the us on 2014 march 10. the customer reported recurring high platelet background counts on the coulter hmx hematology analyzer. there has been no report of death or injury related to this defect.

Device

COULTER ISOTON III DILUENT
  • Model / Serial
    Model Catalog: 8546733 (Lot serial: 50752F)
  • Product Description
    COULTER ISOTON III DILUENT
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.