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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 10 Results
Related Medical Device Recalls Date Classified to: 12/20/2014
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Product Description
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Z-0484-2013 - Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS® AmpliPrep instrument, COBAS® TaqMan® analyzer, COBAS® TaqMan® 48 analyzer, COBAS® AMPLICOR® a... 2 Dec-07-2012 Roche Molecular Systems, Inc.
Z-0485-2013 - 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.... 2 Dec-07-2012 Roche Molecular Systems, Inc.
Z-0486-2013 - 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 is a general purpose instr... 2 Dec-07-2012 Roche Molecular Systems, Inc.
Z-0487-2013 - 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... 2 Dec-07-2012 Roche Molecular Systems, Inc.
Z-0493-2013 - DataCare POC  is an information management system that provides data management functionality for managing point-of -care testing data. 2 Dec-07-2012 Roche Molecular Systems, Inc.
Z-0489-2013 - The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualita... 2 Dec-07-2012 Roche Molecular Systems, Inc.
Z-0490-2013 - The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide rang... 2 Dec-07-2012 Roche Molecular Systems, Inc.
Z-0491-2013 - DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems. 2 Dec-07-2012 Roche Molecular Systems, Inc.
Z-0492-2013 - DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data. 2 Dec-07-2012 Roche Molecular Systems, Inc.
Z-0488-2013 - 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... 2 Dec-07-2012 Roche Molecular Systems, Inc.
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