Recall Z-1370-06 ยท LFR Glucose Dehydrogenase, Glucose
Roche Diagnostics Corp.
ACCU-CHEK Voicemate System, Advantage Blood Glucose Meter and Voice Unit - English language version for the blind or visually impaired, Cat. no 2030802. Ref. no. 12030802001 with meter model no. 768.
| 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
| K982079 | ACCU-CHECK VOICEMATE Boehringer Mannheim Corp., Aug 28, 1998 |