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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Medical Device Notification - Misys Laboratory Blood Bank Module, Version 6.1-Misys Healthcare Systems

DATE NOTIFICATION INITIATED:

March 15, 2006

PRODUCT:

Misys Laboratory Blood Bank Module, Version 6.1

MANUFACTURER:

Misys Healthcare Systems
Tucson, Arizona

REASON:

Misys Healthcare Systems issued a “Product Safety Notice” (PSN-06-01).

Blood bank computer software contains a defect that could cause the data being entered to be out of sync with the accession number, patient and/or unit(s) displayed on the screen. The defect will be corrected with the installation of a software patch.

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002