Medical Device Notification (PSN-08-05)

Sunquest Laboratory Blood Bank and Blood Donor Modules

DATE NOTIFICATION INITIATED:

June 24, 2008

PRODUCT / LOT NUMBER:

Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1, v6.0.2, and v6.4.0 (Beta)
Distributed with Sunquest Laboratory v6.1, v6.2, v6.3 and v6.3.1 (Beta)

MANUFACTURER:

Sunquest Information Systems, Inc.
Tucson, Arizona

REASON:

In the Blood Order Processing Worklist, only in specialize situations, data being entered may be out of sync and saved to a patient other than the one expected. Customers are asked to request the software correction via the Client Support Webpage.


The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

 
Updated: July 17, 2008