Recall Z-0728-2008 ยท NBW System, Test, Blood Glucose, Over The Counter
Invictus Scientific Inc
Invictus-- Bionime Rightest Blood Glucose Monitoring System MODEL: GM300; Invictus Scientific, Inc., San Diego, CA
| Date | Feb 16, 2008 (initiated Nov 26, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 thei |
| Quantity | 21,070 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |