Events

Recall of GALILEO NEO IMMUNO HAEMATOLOGY ANALYZER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by IMMUCOR INC..

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
    137314
  • Event Risk Class
    II
  • Event Initiated Date
    2014-12-11
  • 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
    Following the launch of the last software upgrade to neo install set 2.1 (aurora 2.09) there have been sporadic complaints in which results are not being received in the data management software (dms). users most commonly report that results are not visible in the results folder and/or do not print once processing is complete. when this occurs the user must intervene to try to resend the results to the dms or in many cases repeat the test. in this event the hazard is delay in reporting results. this issue has been linked to reuse of capture plate frames and users are advised to not use a plate frame more than 12 times.

Device

GALILEO NEO IMMUNO HAEMATOLOGY ANALYZER
  • Model / Serial
    Model Catalog: 0064599 (Lot serial: All serial numbers)
  • Product Description
    Galileo NEO Automated Blood Bank System
  • Manufacturer
    IMMUCOR INC.

Manufacturer

IMMUCOR INC.
  • Manufacturer Address
    NORCROSS
  • Manufacturer Parent Company (2017)
    Ivd Holdings Inc
  • Source
    HC