Events

Recall of Device Recall Livongo Health In Touch Blood Glucose Monitoring System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Livongo Health.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73486
  • Event Risk Class
    Class 2
  • Event Number
    Z-1587-2016
  • Event Initiated Date
    2016-02-18
  • Event Date Posted
    2016-04-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-03-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144286
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, test, blood glucose, over the counter - Product Code NBW
  • 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.
  • Action
    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.

Device

Device Recall Livongo Health In Touch Blood Glucose Monitoring System
  • Model / Serial
    Model/Reorder Number 3614-001-001 with the following lot numbers 890071 890072, 890073, 890074, 890075, 890076, 890077, 890078 and 890079.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Manufacturer
    Livongo Health

Manufacturer

Livongo Health
  • Manufacturer Address
    Livongo Health, 444 N Michigan Ave Ste 2880, Chicago IL 60611-3998
  • Manufacturer Parent Company (2017)
    Livongo Health
  • Source
    USFDA