Recall Z-1366-06 ยท CGA Glucose Oxidase, Glucose
Roche Diagnostics Corp.
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. 030002
| Date | Aug 5, 2006 (initiated Jun 22, 2006) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| 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. |
| Quantity | 55,189 meters (for all Recalls Z-1354-1371-06) |
| Distribution | Worldwide, USA, Germany, Guam, North Mariana Islands, Panama and Virgin Islands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K924475 | ACCUDATA GLUCOSE TEST STATION Boehringer Mannheim Corp., Oct 13, 1992 |