Invictus-- Bionime Rightest Blood Glucose Monitoring System MODEL: GM300; Invictus Scientific, Inc., San Diego, CA
Recall
- Recall Number
- Z-0728-2008
- Event Number
- 45953
- Firm
- Invictus Scientific Inc
- FEI Number
- 3005498483
- Product Code
- NBW
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- November 26, 2007
- Posted
- February 16, 2008
- Terminated
- October 13, 2011
- Address
- 11760 Sorrento Valley Rd, Ste G, San Diego, CA, 92121
Description
Invictus-- Bionime Rightest Blood Glucose Monitoring System MODEL: GM300; Invictus Scientific, Inc., San Diego, CA
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.
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.
Nationwide Distribution
21,070