The Livongo Health In Touch Blood Glucose Monitoring System… recallZ-1587-2016 · Livongo Health · initiated Feb 18, 2016
Class II Terminated All recalls posted in April 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Livongo Health or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Error in labeling
What the company is doing
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.
Recall details
- Recall number
- Z-1587-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 18, 2016
- Posted by the FDA
- Apr 29, 2016
- Recalling firm
- Livongo Health
- Quantity
- 63,000 units
- Product code
- NBW
- FDA submissions
- K133584
- 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.
Product description
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 (models, lots, serial numbers)
Model/Reorder Number 3614-001-001 with the following lot numbers 890071 890072, 890073, 890074, 890075, 890076, 890077, 890078 and 890079.
Other devices under the same FDA submission
2 devices cleared under K133584 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Livongo Lancing DeviceLivongo Health, Inc · Lancet, Blood2 reports
- Livongo Test StripsLivongo Health, Inc · Glucose Oxidase, Glucose1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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