Sunquest Information Systems Inc. Class II

Company: Sunquest Information Systems, Inc
Date of Enforcement Report: 4/24/02
Class: II

PRODUCT
Misys Laboratory for Windows version 5.3. Recall # Z-0888-2.

CODE
REASON
Software QA code of BOTH for patient sex can result in QA flags not being generated for abnormal results.

Versions 5.3.

RECALLING FIRM/MANUFACTURER
Sunquest Information Systems, Inc., aka Misys Healthcare Systems Tucson,
AZ, by a temporary procedural workaround March 8, 2002.Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
345.

DISTRIBUTION
Nationwide, internationally to United Kingdom, Ireland, Denmark, Canada, Bermuda and Saudi Arabia.

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.