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

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.