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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
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.
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