Recall Z-0260-2020 ยท NBW System, Test, Blood Glucose, Over The Counter
LABSTYLE INNOVATIONS
Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
| Date | Aug 29, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Software change control |
| Action | The firm released Android App version 4.3.3 on August 29, 2019. Users were informed about the issue via push notification on 8/30/19, asking to update to the new version. An additional push notification was sent on 8/31/19, along with a Field Safety Notice letter sent to their "inbox". On 9/9/19, remaining potential relevant users received a third notification in which they were asked to upgrade their version through in-app and push notifications. Customers were instructed to do the following: Please update the latest Dario - Blood Glucose Tracker Android App version as follows o Open the Goo |
| Quantity | 126,271 (83,141 US; 43,130 OUS) |
| Distribution | Nationwide domestic distribution. Foreign distribution to Australia, Canada, UK, and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150817 | Dario Blood Glucose Monitoring System Labstyle Innovations, Ltd., Dec 21, 2015 |