Events

Recall of UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - TOXO IGM ASSAY

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
    28028
  • Event Risk Class
    III
  • Event Initiated Date
    2013-07-18
  • 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 "interpretation of result" section of the access toxo igm ii data sheet ref ds-14632a for the united states and ref ds-15806a for outside the united states incorrectly lists the reactive and the grey zone results. the access toxo igm ii ifu correctly lists the reactive and grey zone results and the system correctly reports the results.

Device

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - TOXO IGM ASSAY
  • Model / Serial
    Model Catalog: 34470 (Lot serial: ALL)
  • Product Description
    ACCESS TOXO IGM II [FOR UNICEL DXI 800]
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.