Events

Recall of NAVIOS 8 COLORS / 2 LASERS

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
    51053
  • Event Risk Class
    II
  • Event Initiated Date
    2011-10-27
  • 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
    When running a multi-tube worklist there is a slight possibility that a listmode file may be duplicated. when this happens the next tube on the worklist is skipped (not sampled). subsequent tubes on the worklist are processed correctly. the duplicated listmode file contains all of the correct data events and fcs keyword information but will have the skipped tube's listmode filename assigned to it. therefore any panel report generated from the skipped tube may have erroneous but credible results.

Device

NAVIOS 8 COLORS / 2 LASERS
  • Model / Serial
    Model Catalog: A52102 (Lot serial: ALL); Model Catalog: A52103 (Lot serial: ALL)
  • Product Description
    Navios Flow Cytometery Software
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.