ACCU-CHEK Voicemate System, Advantage Blood Glucose Meter and Voice Unit - Spanish language version for the blind or vis
FDA device recall Z-1371-06 · posted 2006-08-05 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LFR
- Quantity affected
- 55,189 meters (for all Recalls Z-1354-1371-06)
- Distribution
- Worldwide, USA, Germany, Guam, North Mariana Islands, Panama and Virgin Islands.
- Date initiated
- 2006-06-22
- Date posted
- 2006-08-05
- Date terminated
- 2008-04-07
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCU-CHECK VOICEMATE (K982079) | Boehringer Mannheim Corp. | 1998-08-28 |