Recall Z-1354-06 ยท CGA Glucose Oxidase, Glucose
Roche Diagnostics Corp.
ACCU-CHEK Advantage Blood Glucose Meter/ Blood Glucose Monitoring System; Cat. no. 870. Ref. no. 080087000 with meter model number 870; Ref. no.0353756001 with meter model number 33304510; Ref. no. 03537536001 with meter model no. 2138930; Ref. no. 03537536001 with meter model no. 3288650.
| Date | Aug 5, 2006 (initiated Jun 22, 2006) |
| Status | Terminated |
| Reason | The meter gives a strip 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 strip error and the manual only instructs the user to retest with a new strip using a larger drop of blood. |
| 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
| K930979 | ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM Boehringer Mannheim Corp., Sep 8, 1993 |