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

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

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