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.
This recall has been terminated (originally issued August 5, 2006).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- June 22, 2006
- Posted
- August 5, 2006
- Terminated
- April 7, 2008
- Recall Number
- Z-1366-06
- Quantity
- 55,189 meters (for all Recalls Z-1354-1371-06)
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide, USA, Germany, Guam, North Mariana Islands, Panama and Virgin Islands.
Lot / Code Info
All units.
Root Cause
Other
Action Taken
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.
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