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
    15398
  • Event Risk Class
    III
  • Event Initiated Date
    2013-06-12
  • 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 identified that the fluorescence photo-multiplier tube (pmt) gain settings displayed in the cytometer control dialog box may not reflect the actual pmt gain settings on the navios flow cytometer. if a change to the fluorescence gain is made at any time to any protocol and saved (or not saved) all subsequently loaded protocols will apply the previously set gain parameters regardless of what the cytometer control dialog is showing. therefore any subsequent protocol may not reflect the actual system gain in the cytometer control dialog box.

Device

NAVIOS 10 COLORS / 3 LASERS
  • Model / Serial
    Model Catalog: A52103 (Lot serial: > 10 numbers contact mfg.); Model Catalog: A52102 (Lot serial: > 10 numbers contact mfg.); Model Catalog: A52101 (Lot serial: > 10 numbers contact mfg.)
  • Product Description
    NAVIOS 10 COLORS / 3 LASERS
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.