FDA-Device2019-11-06Class II
Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
LABSTYLE INNOVATIONS
Hazard
The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2 may experience duplicate logging of a blood glucose level reading.
Sold states
Nationwide domestic distribution. Foreign distribution to Australia, Canada, UK, and Italy.
Affected count
126,271 (83,141 US; 43,130 OUS)
Manufactured in
7, Derekh Menakhem Begin, Ramat Gan, Israel
Products
Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0260-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief