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
    43237
  • Event Risk Class
    I
  • Event Initiated Date
    2018-01-30
  • 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
    If the following sequence of events is followed it will result in sample mis-identification and erroneous results will be generated. the system will not identify or flag the erroneous results. - the stat button is selected within aquios cl software and the user opens the single-tube loader door. - user creates a test request when prompted places a specimen tube in single tube loader and closes the single-tube loader door. - the stat button is selected again and the user opens the single-tube loader door within 15 seconds or less of loading the first sample and before the "details" column on running screen changes to "prepping" for that sample. - user removes the first specimen tube and replaces with a different specimen tube. if another request is entered for the new specimen and the single-tube loader door is closed the new specimen tube will be prepared twice. both test requests will be processed with 2nd specimen tube. if another request is not entered for new specimen and the single-tube loader door is closed the new specimen tube will be prepared once. the first test request will be processed with 2nd specimen tube.

Device

AQUIOS CL FLOW CYTOMETER

Manufacturer

BECKMAN COULTER CANADA L.P.