Livongo Health recalls The Livongo Health In Touch¿ Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) system designed for t…

Recall date

February 18, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1587-2016

FDA classification

Class II

Brand / firm

Livongo Health

Sold / distributed

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.

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.