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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
(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