Z-0728-2008

Invictus-- Bionime Rightest Blood Glucose Monitoring System MODEL: GM300; Invictus Scientific, Inc., San...

Name: Z-0728-2008 Invictus-- Bionime Rightest Blood Glucose Monitoring System MODEL: GM300; Invictus Scientific, Inc., San...
Creator: Invictus Scientific Inc
Published: 2007-11-26
License: https://open.fda.gov/license/

Invictus Scientific Inc / initiated 2007-11-26 / Terminated / root cause: software

FDA source

Invictus Scientific Inc began a recall of Invictus-- Bionime Rightest Blood Glucose Monitoring System MODEL: GM300; Invictus Scientific, Inc., San Diego, CA on 2007-11-26. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0728-2008
Status: Terminated
Initiated: 2007-11-26
Posted: 2008-02-16
Terminated: 2011-10-13
Recalling firm: Invictus Scientific Inc
Product: Invictus-- Bionime Rightest Blood Glucose Monitoring System MODEL: GM300; Invictus Scientific, Inc., San Diego, CA
Product code: NBW System, Test, Blood Glucose, Over The Counter
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.
Root cause tag: software
FDA 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 in commerce: 21,070
Distribution: Nationwide Distribution
Product codes and lots: 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

Product code NBW

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)