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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
(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
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