The Livongo Health In Touch Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) system designed for the
FDA device recall Z-1587-2016 · posted 2016-04-29 · Terminated
Recall details
- Recalling firm
- Livongo Health
- 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
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 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 Carol
- Date initiated
- 2016-02-18
- Date posted
- 2016-04-29
- Date terminated
- 2018-03-06
- Location
- Chicago, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM (K133584) | Eoshealth, Inc. | 2014-09-08 |