Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Dario Blood Glucose Monitoring System Recalled by LABSTYLE INNOVATIONS Due to The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2...

Date: August 29, 2019
Company: LABSTYLE INNOVATIONS
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact LABSTYLE INNOVATIONS directly.

Affected Products

Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2

Quantity: 126,271 (83,141 US; 43,130 OUS)

Why Was This Recalled?

The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2 may experience duplicate logging of a blood glucose level reading.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About LABSTYLE INNOVATIONS

LABSTYLE INNOVATIONS has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report