Events

Recall of AQUIOS CL FLOW CYTOMETER

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
    49649
  • Event Risk Class
    I
  • Event Initiated Date
    2017-10-02
  • 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 aquios cl systems are connected to a laboratory information system (lis) the system may duplicate sample requests leading to sample mis-identification. for this to happen the following conditions must be met: -the aquios cl flow cytometer is connected to an lis and -the aquios cl system has the default test enabled and -host query is enabled in lis setup screen on system and -there are multiple cassettes in the autoloader and -the lis host query response is received in a brief time window before lis response timeout occurs. when all of these conditions are met a sample will follow two (2) paths of test request creation (lis and default test). all software versions (2.0 2.0.1 and 2.1) in existence are impacted by this issue and all applications used on the aquios cl are impacted by this issue.

Device

AQUIOS CL FLOW CYTOMETER

Manufacturer

BECKMAN COULTER CANADA L.P.