Health product recall

Galileo Echo Instrument (2018-03-07)

Starting date:
March 7, 2018
Posting date:
April 3, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-66320

Affected products

Galileo Echo Instrument

Reason

Immucor, Inc. is issuing a medical device recall for Galileo Echo Instrument. Immucor has recently become aware of an issue within the echo software that will cause a software assertion error when loading reagents that have an expiry date greater than December 31, 2019. The echo will not recognize products with an expiry date greater than December 31, 2019.

Affected products

Galileo Echo Instrument

Lot or serial number

Software Version 1.4.1.26.2

Model or catalog number

87000

Companies
Manufacturer

Immucor Inc.

3130 Gateway Drive, P.O. Box 5625

Norcross

30091-5625

UNITED STATES