Events

Recall of NAVIOS 10 COLORS / 3 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
    53040
  • Event Risk Class
    III
  • Event Initiated Date
    2010-07-09
  • 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 an issue with the navious flow cytometer with version 1.0 software: red and violet laser related errors are not displayed in the event of a laser failure. the blue laser is not impacted by this issue.

Device

NAVIOS 10 COLORS / 3 LASERS
  • Model / Serial
    Model Catalog: A52103 (Lot serial: SERIAL NUMBERS AM51001-AS15102); Model Catalog: A52102 (Lot serial: SERIAL NUMBERS AN06024-AS03008); Model Catalog: A52101 (Lot serial: SERIAL NUMBERS AN29103-AS15099)
  • Product Description
    NAVIOS FLOW CYTOMETER
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.