BEUDAMED
    FDA Recall Terminated

    Roche brand Accu-Chek Aviva Meter (mmol/L); Catalog numbers 03532313001 and 03532321001. (Distributed outside of the U.S.)

    Recall: Z-0426-06 · Initiated November 9, 2005

    Recall

    Recall Number
    Z-0426-06
    Event Number
    33862
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    LFR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 9, 2005
    Posted
    January 24, 2006
    Terminated
    June 14, 2007
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche brand Accu-Chek Aviva Meter (mmol/L); Catalog numbers 03532313001 and 03532321001. (Distributed outside of the U.S.)

    Reason

    Incorrect patient blood glucose test results may be reported due to a software problem.

    Action

    Notification letters dated 11/9/05 were issued to Users, Mail Order Distributors, Clinical Trial Sponsors, Pharmacists and Health Care Professionals. Press release issued 1/17/06.

    Distribution

    Nationwide, Belgium, Canada, Germany, Netherlands, Spain and Sweden.