BEUDAMED
    FDA Recall Terminated

    Amplilink Software versions 1.1, 1.3, 1.4, 2.41. COBAS Amplicor CTA & NGA Tests

    Recall: Z-1106-2007 · Initiated May 21, 2007

    Recall

    Recall Number
    Z-1106-2007
    Event Number
    37963
    Firm
    Roche Molecular Systems, Inc.
    FEI Number
    2243471
    Product Code
    JJF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 21, 2007
    Posted
    August 2, 2007
    Terminated
    February 18, 2010
    Address
    1080 US Highway 202 S, Somerville, NJ, 08876-3733

    Description

    Amplilink Software versions 1.1, 1.3, 1.4, 2.41. COBAS Amplicor CTA & NGA Tests

    Reason

    For select COBAS AMPLICOR Tests run on the COBAS AMPLICOR Analyzer in conjunction with AMPLILINK software, a discrepancy has been identified between the onboard working reagent stability information reported by AMPLILINK Software (versions 1.1, 1.3, 1.4 and 2.41) and the stability information provided in the test kit package inserts/method manual.

    Action

    Urgent Medical Device Correction letters were mailed on 5/21/07 by first class mail. Letters describe the discrepancy between software reagent expiration dates and package insert expiration dates.

    Distribution

    Nationwide to hospitals and laboratories.

    Quantity

    5,806 total