Events

Recall of AUTOMATE 2500 SYSTEM

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
    60801
  • Event Risk Class
    III
  • Event Initiated Date
    2015-05-27
  • 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
    An ir sensor module failure can occur and can be identified by one of the following: volume detection error message errid: 5694 timeout error message errid: 5405 system initialization failure of the conveyor belt module. immediately prior to the failure there is a remote possibility that the ir sensor module may not properly detect the sample volume in the tube. the ir sensor module is part of the tube inspection unit (tiu) and is responsible for sample volume detection on automate systems. failure to properly detect the sample volume in the tube may cause an increased number of primary and secondary sample tubes to be transferred to the error workplace on the automate system. as a result of the failure there may be unexpected downtime of the automate system.

Device

AUTOMATE 2500 SYSTEM
  • Model / Serial
    Model Catalog: ODL25250 (Lot serial: 2207); Model Catalog: ODL25250 (Lot serial: 2205)
  • Product Description
    AUTOMATE 2500 SYSTEM
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.