Company:Roche Diagnostics Operations, Inc. . Date of Enforcement Report 1/30/2013 Class ll: PRODUCT Roche COBAS INTEGRA 400 and 400 plus Analyzer The Roche COBAS INTEGRA 400/400 plus Analyzer is a fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids. Recall Number Z-0696-2013 REASON A software...Read More

Company:Becton Dickinson & Co. Date of Enforcement Report 1/30/2013 Class ll: PRODUCT BD MAX ™ (6 channel) Instruments, Catalog number 441916, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152 USA*** The BD MAX” System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification...Read More