BEUDAMED
    FDA Recall Terminated

    Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics, Inc., Indpls., IN; Catalog no. 04522320190. Product is an in vitro diagnostic.

    Recall: Z-0542-2009 · Initiated September 15, 2008

    Recall

    Recall Number
    Z-0542-2009
    Event Number
    49382
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    JIX
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    September 15, 2008
    Posted
    January 6, 2009
    Terminated
    December 1, 2009
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics, Inc., Indpls., IN; Catalog no. 04522320190. Product is an in vitro diagnostic.

    Reason

    Test results, low: Sodium, potassium and chloride results on the cobas 6000 ISE unit may exhibit a downward drift in controls and patient samples within the recommended calibration interval of 24 hours. For further information, please contact Roche Diagnostics Corporation by telephone at 800-428-2336.

    Action

    Consignees were notified by letter dated 9/15/08, which provided a work-around for them to use until the problem can be permanently resolved. The letter was entitled "URGENT MEDICAL DEVICE CORRECTION." For further information, please contact Roche Diagnostics Corporation by telephone at 800-428-2336.

    Distribution

    Nationwide Distribution.

    Quantity

    7909