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
    139054
  • Event Risk Class
    III
  • Event Initiated Date
    2013-08-29
  • 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 determined that the navios flow cytometer instructions for use (ifu) states that when a drip chamber level warning occurs the instrument will acquire for at least 5 minutes longer after the drip chamber level warning message is displayed. however the system may only acquire for as little as 3 minutes after the drip chamber level warning and will provide drip chamber level error. at that time the instrument will abort acquisition and does not save the listmode file and data are lost.

Device

NAVIOS 8 COLORS / 2 LASERS
  • Model / Serial
    Model Catalog: A52102 (Lot serial: >10 contact manufacturer); Model Catalog: A52103 (Lot serial: >10 contact manufacturer)
  • Product Description
    Navios 8 Colors/2 Lasers
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.