The Recall Desk
ModerateFDA (Devices)·Z-0260-2020·Announced 2019-11-06

Dario Blood Glucose Monitoring System App Recall for Duplicate Logging

Labstyle Innovations is recalling the Dario Blood Glucose Monitoring System Android app versions 4.3.0-4.3.2 because it may duplicate blood glucose readings.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a software defect causing duplicate data logging rather than a direct physical injury or acute health threat, fitting the criteria for moderate severity.

Plain-English summary

Labstyle Innovations is recalling the Dario Blood Glucose Monitoring System, Model No. 1015-05, specifically the Android app software versions 4.3.0 through 4.3.2. The recall involves 126,271 units, with 83,141 distributed in the United States and 43,130 distributed outside the US to Australia, Canada, the UK, and Italy.

The recall was initiated because the affected software versions may experience duplicate logging of a blood glucose level reading. This defect could result in inaccurate data records for users relying on the application to track their health metrics.

Consumers using the Dario Blood Glucose Monitoring System should check their Android app version. If the software version is 4.3.0, 4.3.1, or 4.3.2, they should contact Labstyle Innovations for instructions on how to resolve the issue or obtain a replacement.

The recalled product

Product
Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
Manufacturer
LABSTYLE INNOVATIONS
Category
Medical Device — Blood Glucose Monitoring
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Android App Software versions 4.3.0-4.3.2

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · software defect

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