FDA Medical Device Recalls (openFDA)
Invictus Scientific Inc: Invictus-- Bionime Rightest Blood Glucose Monitoring System MODEL: GM300; Invictus Scientific, Inc., San Diego, CA
- Recall number
- Z-0728-2008
- Recalling firm
- Invictus Scientific Inc
- Product
- Invictus-- Bionime Rightest Blood Glucose Monitoring System MODEL: GM300; Invictus Scientific, Inc., San Diego, CA
- Status
- Terminated
- Initiated
- 2007-11-26
- Posted
- 2008-02-16
- Terminated
- 2011-10-13
- 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 their outstanding recalled stocks. If customers have any questions, they were instructed to contact at 858-481-8485.
- Quantity
- 21,070
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot Numbers: 1FF19C0001 to 1FF19C0020, 1FF05C0001 to 1FF05C5000, 2FH15C0001 to 2FH15C4800, 230GBB0001 to 230GBB0050, 230GFF0001 to 230GFF0600, 230GFF0601 to 230GFF1200, 230GFF1201 to 230GFF1996, 230GHC0001 to 230GHC3204, 230GHC3205 to 230GHC4204, 230GHJ0001 to 230GHJ5000, 230GHJ5001 to 230GHJ6992, and 230GIB0001 to 230GIB3008
- 510(k) numbers
- ["K042678","K053635","K062567"]
- PMA numbers
- not on file
- Product code
- NBW
- Firm FEI
- 3005498483
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28