Medical device recalls Moderate risk

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

Recall date
August 29, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0260-2020
FDA classification
Class II
Brand / firm
LABSTYLE INNOVATIONS
Sold / distributed
Nationwide domestic distribution. Foreign distribution to Australia, Canada, UK, and Italy.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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