Events

Recall of GALILEO IMMUNO HAEMATOLOGY SYSTEM - GALILEO INSTRUMENT

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
    22185
  • Event Risk Class
    II
  • Event Initiated Date
    2010-07-30
  • 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
    If an unrecognized rack is removed and a sample is than removed or switched in the rack followed by reinserting the rack into the lane it is possible for the sample id that originally occupied the possition to be assigned to the newly loaded sample or the the empty position. under these conditions it is possible that results will be associated with the wrong sample.

Device

GALILEO IMMUNO HAEMATOLOGY SYSTEM - GALILEO INSTRUMENT
  • Model / Serial
    Model Catalog: 0064999 (Lot serial: N.A.)
  • Product Description
    GALILEO BLOOD BANK ANALYZER
  • Manufacturer
    IMMUCOR INC.

Manufacturer

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