BEUDAMED
    FDA Recall Terminated

    AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 03563383001, catalog number 04855094001, catalog number 04807197001, catalog number 04862392001, catalog number 05093236001, and catalog number 05201357001. Automated sample preparation for nucleic acid analysis on either the COBAS TaqMan or COBAS TaqMan 48. COBAS AmpliPrep/COBAS TaqMan is capable of tunning HBV, HCV, and HIV tests.

    Recall: Z-1928-2009 · Initiated June 2, 2009

    Recall

    Recall Number
    Z-1928-2009
    Event Number
    52118
    Firm
    Roche Molecular Systems, Inc.
    FEI Number
    2243471
    Product Code
    JJH
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 2, 2009
    Posted
    August 27, 2009
    Terminated
    August 13, 2010
    Address
    1080 US Highway 202 S, Somerville, NJ, 08876-3733

    Description

    AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 03563383001, catalog number 04855094001, catalog number 04807197001, catalog number 04862392001, catalog number 05093236001, and catalog number 05201357001. Automated sample preparation for nucleic acid analysis on either the COBAS TaqMan or COBAS TaqMan 48. COBAS AmpliPrep/COBAS TaqMan is capable of tunning HBV, HCV, and HIV tests.

    Reason

    Software bug: A unique series of events involving the COBAS AmpliPrep instrument running AMPLILINK software version 3.2.2 that results in specimens being amplified and detected with the wrong parameters. The error can occur on either COBAS AmpliPrep/COBAS TaqMan 48, COBAS AmpliPrep/COBAS TaqMan (docked) or cobas s 201 system (docked) running Amplilink Software versions 3.1 or 3.2 series up to and

    Action

    Urgent Medical Device Correction Letters were sent on June 2, 2009 by first class mail. The letter described the issue; impact on results; clinical implications; the workaround; and the actions required, which include following the workaround until a new version of AMPLILINK software is available and filing the letter for future reference. Questions or concerns should be directed to Roche Diagnostics Technical Support at 1-800-526-1247.

    Distribution

    Nationwide Distribution

    Quantity

    282