Company: Beckman Coulter, Inc. Date of Enforcement Report 11/10/2010 Class ll: PRODUCT UniCel DxC 880i, 860i and 600i Systems; Software Part Number: A84500, A86646; Software version: 4.9.01 The UniCel Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other...Read More

Company: International Technidyne Corp Date of Enforcement Report 11/10/2010 Class lll: PRODUCT Integrated Data Management System – Version 7.1, 7.2 and 7.3; Product code 464100. Recall # Z-2438-2010 REASON A tabulation error in the Integrated Data Management Systems (IDMS) data management software that results in incorrect Electronic Quality Control (EQC) Summary Reports: The Operator and...Read More