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LABSTYLE INNOVATIONS recalls Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
Recalled November 6, 2019 · FDA recall Z-0260-2020 · 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. · FDA Class II
Units
126,271 (83,141 US; 43,130 OUS)
Sold at
Nationwide domestic distribution. Foreign distribution to Australia, Canada, UK, and Italy.
Description
The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2 may experience duplicate logging of a blood glucose level reading.
Product
Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
Manufacturer(s)
LABSTYLE INNOVATIONS
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →