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Galileo Neo Immuno Haematology Analyzer (2017-09-13)
- Starting date:
- September 13, 2017
- Posting date:
- September 26, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-64600
Affected products
- Galileo Neo Immuno Haematology Analyzer
- Galileo Neo (class 4) Immuno Haematology Analyzer
Reason
This recall is to communicate the installation of an update to the Weak D assay on the NEO instrument. This update has been developed to resolve potential invalid results generated when the negative control well (well C1) reacts unexpectedly strongly positive due to droplet accumulation.
Affected products
A. Galileo Neo Immuno Haematology Analyzer
Lot or serial number
All serial numbers
Model or catalog number
64599
Companies
- Manufacturer
-
Immucor Inc.
3130 Gateway Drive, P.O. Box 5625
Norcross
30091-5625
Georgia
UNITED STATES
B. Galileo Neo (class 4) Immuno Haematology Analyzer
Lot or serial number
All serial numbers
Model or catalog number
64599
Companies
- Manufacturer
-
Immucor Inc.
3130 Gateway Drive, P.O. Box 5625
Norcross
30091-5625
Georgia
UNITED STATES