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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Field Correction: Galileo Blood Bank Analyzer-Immucor, Inc

DATE FIELD-CORRECTION INITIATED:

March 30, 2006

PRODUCT

Galileo Blood Bank Analyzer
Catalog Number 0064997 and 0064999

MANUFACTURER:

Immucor, Inc.
Norcross, Georgia

REASON:

Immucor has notified their consignees who have Galileo software version 20060220-SP8.1 loaded on their Galileo Blood Bank Analyzers that this version contained a change to the weak D assays (Weak_D and Weak_D_F) in which the pipetting order of the anti-D reagent and Monoclonal Control was reversed. Because of this change, the order of the well reactions as it pertains to the exporting of the assay results is also reversed. This contradicts the information contained in the Galileo Interface Export Protocol included in the operator manual and the information provided to the LIS (Laboratory Information System) vendors.

Depending how your LIS is configured, this could impact interpretations within your LIS. If your LIS is configured to import only the test interpretations provided by the Galileo, then this change will have no effect on the LIS result. However, if your LIS imports the reactions and the LIS makes an interpretation based on those reactions, then the possibility of an incorrect result exists. Customers are asked to verify if their LIS performs an interpretation rather than using the Galileo interpretation.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448