Z-1587-2016Class II

The Livongo Health In Touch Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) system...

Name: Z-1587-2016 The Livongo Health In Touch Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) system...
Creator: Livongo Health
Published: 2016-02-18
License: https://open.fda.gov/license/

Livongo Health, Inc. / initiated 2016-02-18 / Terminated / root cause: labeling and UDI

FDA source

Livongo Health began a recall of 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... on 2016-02-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1587-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-18
Posted: 2016-04-29
Terminated: 2018-03-06
Recalling firm: Livongo Health, Inc.
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.
Product code: NBW System, Test, Blood Glucose, Over The Counter
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
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
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.
Quantity in commerce: 63,000 units
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 codes and lots: Model/Reorder Number 3614-001-001 with the following lot numbers 890071 890072, 890073, 890074, 890075, 890076, 890077, 890078 and 890079.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1587-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1587-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-11	2016-04-29

Product code NBW

K133584Class IIIn Touch Blood Glucose Monitoring SystemEoshealth, Inc. / cleared 2014-09-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)