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
    75810
  • Event Risk Class
    III
  • Event Initiated Date
    2012-02-16
  • 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
    The dxi instruments are class 1 laser products that use two class 2 laser products (bar code readers) internal to the instrument. as part of an internal review it was determined the dxi instruments are not compliant to standards regarding identification of laser class inspection of laser labels and information in the operator guide and service manual documentation.

Device

UNICEL DXI 800 ACCESS IMMUNOASSAY - ANALYZER-CLASS 3
  • Model / Serial
    Model Catalog: 973100 (Lot serial: ALL); Model Catalog: A71460 (Lot serial: ALL); Model Catalog: A30260 (Lot serial: ALL); Model Catalog: A71456 (Lot serial: ALL); Model Catalog: 4768 (Lot serial: ALL); Model Catalog: 4771 (Lot serial: ALL); Model Catalog: 4773 (Lot serial: ALL); Model Catalog: 4772 (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.