CLASS II Device recall · Reported 11 May 2016 · FDA Enforcement Report

In Touch¿ Blood Glucose Monitoring System (BGMS) recalled

Livongo Health is recalling In Touch¿ Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (, distributed in 22 states. The recall was initiated on 18 Feb 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Reorder Number 3614-001-001 with the following lot numbers 890071 890072, 890073, 890074, 890075, 890076, 890077, 890078 and 890079.

Quantity recalled63,000 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1587-2016
FDA event ID: 73486
Recalling firm: Livongo Health, Chicago, IL
Classification: Class II
Status: Terminated
Recall initiated: 18 Feb 2016
FDA classified: 29 Apr 2016
Reported: 11 May 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Insulin Pumps & Glucose Monitors

Timeline

18 Feb 2016	Recall initiated by company
29 Apr 2016	Classified by FDA	+71 days
11 May 2016	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was 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.

Arizona California Delaware Florida Georgia Illinois Kentucky Maryland Michigan Minnesota Missouri Mississippi Montana New Jersey New York Ohio Pennsylvania South Carolina Tennessee Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

Model/Reorder Number 3614-001-001 with the following lot numbers 890071 890072, 890073, 890074, 890075, 890076, 890077, 890078 and 890079.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other Insulin Pumps & Glucose Monitors recalls

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26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	CA
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