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
    51025
  • Event Risk Class
    III
  • Event Initiated Date
    2016-09-01
  • 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
    This medical device recall is to communicate the release of a washer firmware update 04.0019 on the galileo neo. this firmware update is intended to reduce the occurrence of false errors with the washer liquid level sense (lls) function during initialization or assay processing on the neo. the lls function checks for inadequate volume before and after each assay wash. this firmware update will be applied to neo systems currently operating with instrument control software (ics) 1.5.10.7. immucor has determined that unexpected (false) lls errors are linked to the presence of excessive salt accumulation.

Device

GALILEO NEO IMMUNO HAEMATOLOGY ANALYZER
  • Model / Serial
    Model Catalog: 0064599 (Lot serial: ICS 1.5.10.7)
  • Product Description
    Galileo NEO Immunohaematology Analyzer
  • Manufacturer
    IMMUCOR INC.

Manufacturer

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