Cl II Sunquest Lab Blood Bank & Blood Donor

Company: Sunquest Information Systems, Inc.,
Date of Enforcement Report 2/11/2008
Class:ll

PRODUCT
Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1 and v6.0.2
Distributed with Sunquest Laboratory v6.1, v6.2 and v6.3

REASON
In both the Blood Bank and Blood Donor modules, a problem has been identified in Blood Order Processing. The system does not trigger all Quality Assurances messages when reaction result grids are enabled. The problem only occurs in specialized situations. Customers are asked to request the software correction via the Client support Webpage.

RECALLING FIRM/MANUFACTURER
Sunquest Information Systems, Inc.
Tucson, Arizona

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.