Recall Z-1587-2016— Livongo Health
Class II · Terminated
Class II FDA medical device recall by Livongo Health, initiated 2016-02-18, terminated 2018-03-06. It names one FDA 510(k) clearance: K133584. 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.. 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.
- Recalling firm
- Livongo Health
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-18
- Terminated
- 2018-03-06
- Firm location
- Chicago, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.