Events

Recall of UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM - INSTRUMENT CLASS 2

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
    32331
  • Event Risk Class
    II
  • Event Initiated Date
    2009-10-28
  • 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
    A software issue was identified in system software 4.2 and 4.2.1 which may result in the incorrect handling of a wash arm dispense plate motion failure. instead of generating a red 'warning' event and stopping sample processing the system will post a yellow 'caution' event and continue to operate with the dispense plate in an elevated position until the instrument is reinitialized. potentially affected results are not flagged.

Device

UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM - INSTRUMENT CLASS 2
  • Model / Serial
    Model Catalog: A30260 (Lot serial: NA); Model Catalog: 4771 (Lot serial: NA); Model Catalog: A71461 (Lot serial: NA); Model Catalog: 973100 (Lot serial: NA); Model Catalog: A71457 (Lot serial: NA); Model Catalog: 4768 (Lot serial: NA); Model Catalog: 4773 (Lot serial: NA); Model Catalog: 4772 (Lot serial: NA)
  • Product Description
    UNICEL DXI600 ACCESS IMMUNOASSAY SYSTEM
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.