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U.S. Department of Health and Human Services

Class 2 Device Recall Livongo Health In Touch Blood Glucose Monitoring System

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  Class 2 Device Recall Livongo Health In Touch Blood Glucose Monitoring System see related information
Date Initiated by Firm February 18, 2016
Date Posted April 29, 2016
Recall Status1 Terminated 3 on March 06, 2018
Recall Number Z-1587-2016
Recall Event ID 73486
510(K)Number K133584  
Product Classification System, test, blood glucose, over the counter - Product Code NBW
Product The Livongo Health In Touch¿ Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) system designed for the self- monitoring of blood glucose by persons with diabetes in home settings to aid in their diabetes management.
Code Information Model/Reorder Number 3614-001-001 with the following lot numbers 890071 890072, 890073, 890074, 890075, 890076, 890077, 890078 and 890079. 
Recalling Firm/
Manufacturer		 Livongo Health
444 N Michigan Ave Ste 2880
Chicago IL 60611-3998
For Additional Information Contact Michael Chibbaro
404-718-5657
Manufacturer Reason
for Recall		 The instructional insert for the In Touch Control Solution for use with the In Touch meter and In Touch strips as a quality control check did not contain the limitation of sensor accuracy: (1) with the use of acetaminophen (Tylenol) (2) with the use of Ascorbic Acid (vitamin C) supplementation (3) in the presence of uric acid
FDA Determined
Cause 2		 Error in labeling
Action The recall was conducted in three distinct events. Members were first sent an e-mail of the Recall Notification - Livongo Test Strip Insert (Event 1) containing information regarding the test strip insert discrepancy. Following the e-mail distribution, a hard copy of the same information was distributed (Event 2) to members via United States Postal\ Service (USPS) mail. Lastly, a second e-mail (Event 3) containing the same information was sent to members. The distribution list for the second (hardcopy distribution) and third (e-mail distribution) events was a subset of the initial member distribution.
Quantity in Commerce 63,000 units
Distribution US consignees: Arizona, California, Delaware, Florida, Georgia, Illinois, Kentucky, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NBW and Original Applicant = EOSHEALTH, INC.
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