Inc, Cl Il Sunquest Information Systems

Company: Sunquest Information Systems, Inc
Date of Enforcement Report 8/20/2008
Class:ll

PRODUCT
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); Recall # B-1740-08

REASON
Software, with a glitch or defect, was distributed

RECALLING FIRM/MANUFACTURER
Sunquest Information Systems, Inc., Tucson AZ, by e-mail on June 24, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
276 Nationwide and 14 Internationally

DISTRIBUTION
Nationwide and Internationally

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.