BEUDAMED
    FDA Recall Terminated

    AccuData GTS Plus for Blood Glucose Monitoring and Automated Data Management including GTS Plus with Accu-Chek Advantage blood glucose meter, Cat no. 3000249 and/or GTS with Accu-Chek Advantage blood glucose meter, Cat. no. 404, and/or Replacement GTS with Accu-Chek Advantage blood gulcose meter, Cat. no. 404R, and/or Replacement Base Unit with Advantage Module, Cat. no. 3426050. Ref. nos. 030002490001 and 03136833001 both have meters with model no. 777.

    Recall: Z-1366-06 · Initiated June 22, 2006

    Recall

    Recall Number
    Z-1366-06
    Event Number
    35022
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 22, 2006
    Posted
    August 5, 2006
    Terminated
    April 7, 2008
    Address
    9115 Hague Rd, Indianapolis, IN, 46250-0416

    Description

    AccuData GTS Plus for Blood Glucose Monitoring and Automated Data Management including GTS Plus with Accu-Chek Advantage blood glucose meter, Cat no. 3000249 and/or GTS with Accu-Chek Advantage blood glucose meter, Cat. no. 404, and/or Replacement GTS with Accu-Chek Advantage blood gulcose meter, Cat. no. 404R, and/or Replacement Base Unit with Advantage Module, Cat. no. 3426050. Ref. nos. 030002490001 and 03136833001 both have meters with model no. 777.

    Reason

    The meter gives an error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a bad strip.

    Action

    A recall notification letter dated April 24, 2006 was sent to each customer alerting them to the fact that this error code has a dual meaning. New software will be installed in all meters when it becomes available.

    Distribution

    Worldwide, USA, Germany, Guam, North Mariana Islands, Panama and Virgin Islands.

    Quantity

    55,189 meters (for all Recalls Z-1354-1371-06)