Company: Roche Molecular Systems, Inc. Date of Enforcement Report 12/19/12 Class ll: PRODUCT Roche Molecular Biochemicals LightCycler 1.2 with software version 3.5. LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve...Read More

Company: Roche Molecular Systems, Inc. Date of Enforcement Report 12/19/12 Class ll: PRODUCT Roche MagNA Pure 96 System Version 1.0 (Software Version 2.0) for in vitro diagnostic use. The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This...Read More

Company: Roche Molecular Systems, Inc. Date of Enforcement Report 12/19/12 Class ll: PRODUCT Roche LightCycler 2.0 Instrument with software version 4.1. LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve...Read More

Company: Roche Molecular Systems, Inc. Date of Enforcement Report 12/19/12 Class ll: PRODUCT Roche Applied Science MagNA Pure LC Version 3.0. The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials. Recall Number Z-0485-2013...Read More

Company: Mindray DS USA Date of Enforcement Report 12/19/12 Class ll: PRODUCT DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable)....Read More

Company: Roche Molecular Systems Inc. Date of Enforcement Report 12/19/12 Class ll: PRODUCT DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems. Recall Number Z-0491-2013 REASON Symantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which...Read More

Company: Roche Molecular Systems, Inc. Date of Enforcement Report 12/19/12 Class ll: PRODUCT DataCare POC  is an information management system that provides data management functionality for managing point-of -care testing data. Recall Number Z-0493-2013 REASON Symantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older),...Read More

Company: Roche Molecular Systems, Inc. Date of Enforcement Report 12/19/12 Class ll: PRODUCT DataCare GM DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data. Recall Number Z-0492-2013 REASON Symantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and...Read More