Company: Roche Diagnostics Operations, Inc. Date of Enforcement Report:12/25/2013 Class lI: PRODUCT MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) by the use of the specially designed MagNA Pure...Read More

Company: Beckman Coulter Inc. Date of Enforcement Report:12/25/2013 Class lI: PRODUCT Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Recall Number Z-0519-2014 REASON Beckman Coulter is initiating a recall for the...Read More