Events

Recall of UNICEL DXI 800 ACCESS IMMUNOASSAY - ANALYZER-CLASS 3

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
    33352
  • Event Risk Class
    II
  • Event Initiated Date
    2010-07-08
  • 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 confirmed the following issue with the software version 4.3. being used in the unicel dxi 600 and dxi 800 access immunoassay systems. if a laboratory changed a default sample type setting on the tests screen while running unicel dxi system software version 4.3 the new setting would not be saved to the system database. the changed sample type setting would reset to the previously saved setting when power was interrupted to the system or if an operator rebooted the system.

Device

UNICEL DXI 800 ACCESS IMMUNOASSAY - ANALYZER-CLASS 3
  • Model / Serial
    Model Catalog: 973100 (Lot serial: ALL); Model Catalog: A30260 (Lot serial: ALL)
  • Product Description
    UNICEL DXI 800 ACCESS IMMUNOASSAY - ANALYZER-CLASS 3
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.