| Class 2 Device Recall Livongo Health In Touch Blood Glucose Monitoring System | |
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
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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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = NBW
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