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Galileo NEO Immunohaematology Analyzer
- Starting date:
- September 1, 2016
- 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-60258
Affected Products
- Galileo Neo Immunohaematology Analyzer
- Galileo Neo Immunohaematology Analyzer
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.
Affected products
A. Galileo Neo Immunohaematology Analyzer
Lot or serial number
ICS 1.5.10.7
Model or catalog number
0064599
Companies
- Manufacturer
-
Immucor Inc.
3130 Gateway Drive, P.O. Box 5625
Norcross
30091-5625
Georgia
UNITED STATES
B. Galileo Neo Immunohaematology Analyzer
Companies
- Manufacturer
-
Immucor Inc.
3130 Gateway Drive, P.O. Box 5625
Norcross
30091-5625
Georgia
UNITED STATES