Invictus-- Bionime Rightest Blood Glucose Monitoring System MODEL: GM300; Invictus Scientific, Inc., San Diego, CA
FDA device recall Z-0728-2008 · posted 2008-02-16 · Terminated
Recall details
- Recalling firm
- Invictus Scientific Inc
- Reason for recall
- Abnormal Memory Recall: When the meter is fixed in 12 hour mode, the time frame display of all memory data will be shown incorrectly as AM or PM depending on when the user is recalling the memory stored in the meter. This will cause confusion as to when the last test was taken.
- Action taken
- An Urgent: Device Recall Notification letter were sent to customers (direct accounts) beginning on November 20, 2007, via US Postal Service, with a return receipt requested. The distributors were instructed to inform consumers/users to fix the time format to the 24 hrs mode and to contact the distributors or the firm for replacement, if they prefer to use the time format in the 12 hrs mode. They were also instructed that if they have further distributed any of the recalled products, to please immediately contact those accounts and advise them of the recall situation, and have them return their outstanding recalled stocks. If customers have any questions, they were instructed to contact at 858-481-8485.
- Root cause
- Software design
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 21,070
- Distribution
- Nationwide Distribution
- Date initiated
- 2007-11-26
- Date posted
- 2008-02-16
- Date terminated
- 2011-10-13
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM (K062567) | Bionime Corporation | 2007-02-16 |
| MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM (K053635) | Bionime Corporation | 2006-02-21 |
| RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM (K042678) | Bionime Corporation | 2005-01-03 |