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U.S. Department of Health and Human Services

Class 3 Device Recall Bionime Rightest Blood Glucose Monitoring System

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 Class 3 Recall
Bionime Rightest Blood Glucose Monitoring System
see related information
Date Posted February 16, 2008
Recall Status1 Open
Recall Number Z-0728-2008
Recall Event ID 45953
Premarket Notification
510(K) Numbers
K042678  K053635  K062567 
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
Product Invictus-- Bionime Rightest Blood Glucose Monitoring System MODEL: GM300; Invictus Scientific, Inc., San Diego, CA
Code Information 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
Recalling Firm/
Manufacturer
Invictus Scientific Inc
11760 Sorrento Valley Rd, Ste G
San Diego, California 92121
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NBW and Original Applicant = BIONIME CORPORATION
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