Roche Molecular Systems, Inc.: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.

Agency Publication Date: December 7, 2012

Affected Products

Product: 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¿ analyzer, and Cobas p 630 instrument for sample preparation, amplification and detection of PCR (Polymerase Chain Reaction) molecular diagnostic analytes.

Device-associated diagnostic software

Product: 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.

Device-associated diagnostic software

Product: 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 instrument. There are no corresponding assays.

Device-associated diagnostic software

Product: 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 analysis with corresponding assays.

Device-associated diagnostic software

Product: 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 analysis.

Device-associated diagnostic software

Product: 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 qualitative and quantitative in-vitro determinations using a wide variety of tests.

Device-associated diagnostic software

Product: 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 range of analytes in various body fluids.

Device-associated diagnostic software

Product: DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.

Device-associated diagnostic software

Product: DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.

Device-associated diagnostic software

Product: DataCare POC is an information management system that provides data management functionality for managing point-of -care testing data.

Device-associated diagnostic software

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 63312

Status: Resolved

Manufacturer: Roche Molecular Systems, Inc.

Manufactured In: United States

Units Affected: 10 products (884 units; 816 units; 13 units; 3,772 units; 1,213 units; 77 units; 855 units.; 1,015 units; 479 units; 126 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

Device-associated diagnostic software

Product: DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.

Device-associated diagnostic software

Product: DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.

Device-associated diagnostic software

Product: DataCare POC is an information management system that provides data management functionality for managing point-of -care testing data.

Device-associated diagnostic software