Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
FDA Recall Z-0260-2020 · Posted None
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Recalling FirmLABSTYLE INNOVATIONS
Recall StatusTerminated
Product CodeNBW
Date Initiated2019-08-29
Date Terminated2020-05-05
Product Quantity126,271 (83,141 US; 43,130 OUS)
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.
Firm 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 Google Play store
o Search for Dario Blood Glucose Tracker App
o Press Uninstall button
o Press OK to confirm the question "Do you want to uninstall this app?"
o Once completed, press Install and verify you installed 4.3.3 version (or above) by pressing the "About this App" link.
Customers with questions should contact the firm's Customer Service Center at 1-800-895-5921, Monday Friday, 9AM 5PM Eastern.
Root Cause
Software change control
Distribution Pattern
Nationwide domestic distribution. Foreign distribution to Australia, Canada, UK, and Italy.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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