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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