Events

Recall of ACCESS IMMUNOASSAY SYSTEM - 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
    109792
  • Event Risk Class
    II
  • Event Initiated Date
    2014-09-29
  • 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 determined that the access 2 console pc (b23083) may experience an "mfc exception" error during normal operation. if this error occurs the system will exit the access 2 user interface (ui) screen and display a window that notifies the user of a "0==itubescancount" event. if the ui is re-launched the system will prevent access to the sample manager screen to request samples for processing and the same "mfc exception" error will occur.

Device

ACCESS IMMUNOASSAY SYSTEM - ANALYZER CLASS 3
  • Model / Serial
    Model Catalog: 81600N (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 4767 (Lot serial: 800135); Model Catalog: 4767 (Lot serial: 800074)
  • Product Description
    ACCESS 2 IMMUNOASSAY SYSTEMS (DL 15633)
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.