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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 and Blood Donor, Version 6.1-Misys Healthcare System

DATE NOTIFICATION INITIATED:

May 20, 2005

PRODUCT:

Misys Laboratory Blood Bank and Blood Donor, Version 6.1

MANUFACTURER:

Misys Healthcare System
Tuscon, AZ

REASON:

Misys Healthcare Systems issued a "Product Safety Notice" (PSN 05-03).

Information entered into the comment field may be lost when resulting the blood type for the first time via a blood bank instrument interface. The software problem 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