Ramat Gan, Israel
LABSTYLE INNOVATIONS recalls
1 recall recorded since 2018, most recently on 29 August 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 29 August 2019
- Terminated
- 5 May 2020
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0260-2020
- Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.