Recall Z-0260-2020— LABSTYLE INNOVATIONS

Name: FDA recall Z-0260-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-29

Class II · Terminated

Class II FDA medical device recall by LABSTYLE INNOVATIONS, initiated 2019-08-29, terminated 2020-05-05. It names one FDA 510(k) clearance: K150817. Product: Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2. Reason: The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2 may experience duplicate logging of a blood glucose level reading..

Recalling firm: LABSTYLE INNOVATIONS
Classification: Class II
Status: Terminated
Initiated: 2019-08-29
Terminated: 2020-05-05
Firm location: Ramat Gan, Israel

510(k) clearances named in this recall

1 on FDA's record

K150817 — Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd.·cleared 2015-12-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.