The Livongo Health In Touch¿ Blood Glucose Monitoring System — Class II medical device recall Z-1587-2016
Terminated recall by Livongo Health, reported 2016-05-11, distributed in AZ, CA, DE, FL, GA, IL, KY, MD…. The instructional insert for the In Touch Control Solution for use with the In Touch meter and In Touch strips
| Recall number | Z-1587-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Livongo Health, Chicago, IL, United States |
| Recall initiated | 2016-02-18 |
| Classified | 2016-04-29 |
| Reported by FDA | 2016-05-11 |
| Terminated | 2018-03-06 |
| Distributed | AZ, CA, DE, FL, GA, IL, KY, MD, MI, MN, MO, MS, MT, NJ, NY, OH, PA, SC, TN, TX, VA, WA |
| Quantity | 63,000 units |
| Lot numbers | 890071, 890072, 890073, 890074, 890075, 890076, 890077, 890078, 890079 |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1587-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.