Recall Z-1587-2016 ยท NBW System, Test, Blood Glucose, Over The Counter
Livongo Health
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.
| Date | Apr 29, 2016 (initiated Feb 18, 2016) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 distr |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133584 | IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM Eoshealth, Inc., Sep 8, 2014 |