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
    60808
  • Event Risk Class
    III
  • Event Initiated Date
    2017-04-05
  • 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 an issue on the aquios where the export feature located in the results area of the aquios system software is not correctly exporting tetra combo crd files. upon import of the exported file to another aquios workstation two individual files will be generated in the results tab rather than one combo file.

Device

AQUIOS CL FLOW CYTOMETER
  • Model / Serial
    Model Catalog: B30166 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    AQUIOS CL FLOW CYTOMETER
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.