FDA recall Z-0260-2020

Product

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.

Distribution

Nationwide domestic distribution. Foreign distribution to Australia, Canada, UK, and Italy.

Key facts

Status

Terminated

Initiation date

2019-08-29

Report date

2019-11-06

Termination date

2020-05-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ramat Gan, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0260-2020