Company: Sunquest Information Systems, IncDate of Enforcement Report: 4/10/02 Class: II PRODUCT FlexiLab Laboratory Information System. Recall # Z-0710-2. REASON Date Format Issue–Flexilab Software converts specimen collect and receipt dates to American standard format ‘mm/dd/yyyy’. For sites using the Euro date format this can alter the generation of QA warnings or flags based on collect...Read More

Company: Roche Diagnostics CorpDate of Enforcement Report: 4/10/02 Class: II PRODUCT All DataCare Systems Software, as follows: a) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9200 b) DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9201...Read More