The Recall Desk

FDA (Devices) recall action 63312

Roche Molecular Systems, Inc. recalled 10 products on 2012-12-19

The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.

Products
10
Announced
2012-12-19
Critical
0
Units
9,250

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–10 of 10

  • ModerateFDA (Devices)··2012-12-19

    Roche Recalls COBAS INTEGRA 400 Analyzer Software Due to Diagnostic Issue

    Roche Molecular Systems is recalling 855 COBAS INTEGRA 400/400 plus systems due to a device-associated diagnostic software issue.

    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-12-19

    Roche MagNA Pure LC Software Recall for Diagnostic Issue

    Roche Molecular Systems is recalling 816 MagNA Pure LC instruments due to a device-associated diagnostic software issue.

    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-12-19

    Roche DataCare POC Software Recalled for Diagnostic Issue

    Roche Molecular Systems is recalling 126 units of DataCare POC software due to a device-associated diagnostic issue.

    Product
    DataCare POC  is an information management system that provides data management functionality for managing point-of -care testing data.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-12-19

    Roche Data Station AMPLILINK Software Recalled for Device-Associated Issue

    Roche Molecular Systems is recalling Data Station AMPLILINK software due to a device-associated diagnostic software issue. The software is used with various COBAS instruments for molecular diagnostics.

    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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-12-19

    Roche MagNA Pure 96 System Software Recall

    Roche Molecular Systems is recalling 13 MagNA Pure 96 Systems due to a device-associated diagnostic software issue.

    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-12-19

    Roche DataCara GM Software Recalled for Diagnostic Issue

    Roche Molecular Systems is recalling DataCara GM software due to a device-associated diagnostic issue. 479 units were distributed nationwide.

    Product
    DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-12-19

    Roche DataInnovations Instrument Manager Software Recalled for Diagnostic Issue

    Roche Molecular Systems is recalling DataInnovations Instrument Manager software due to a device-associated diagnostic software issue.

    Product
    DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-12-19

    Roche COBAS 8000 Analyzer Software Recall for Diagnostic Issue

    Roche Molecular Systems is recalling 77 COBAS 8000 modular analyzers nationwide due to a device-associated diagnostic software issue.

    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-12-19

    Roche LightCycler 1.2 Diagnostic Software Recalled for Device-Associated Issue

    Roche Molecular Systems is recalling LightCycler 1.2 software due to a device-associated diagnostic software issue. The recall covers 3,772 units distributed nationwide.

    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-12-19

    Roche Recalls LightCycler 2.0 Instrument Due to Diagnostic Software Issue

    Roche Molecular Systems is recalling 1,213 LightCycler 2.0 instruments due to a device-associated diagnostic software issue.

    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.
    Category
    Distribution
    0 states