Accu-Chek Connect App Recall for Android Data Transfer Failure
Roche Diabetes Care is recalling the Accu-Chek Connect App because users on Android OS 8.0 and above may be unable to transfer meter values to the app.
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, but the hazard is a software functionality failure (data transfer) rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity software defect.
Plain-English summary
Roche Diabetes Care, Inc. is recalling the Accu-Chek Connect Diabetes Management App. The recall affects version 2.1.6.3 of the application when used with Android OS 8.0 and above.
The recall was initiated because users with these specific operating system versions may be unable to transfer values obtained on their meter to the App. This issue prevents the synchronization of diabetes management data between the hardware meter and the software application.
The recall is for nationwide and worldwide usage of the Connect App. Consumers should check their app version and operating system to determine if they are affected.
The recalled product
- Product
- Accu-Chek Connect Diabetes Management App
- Manufacturer
- Roche Diabetes Care, Inc.
- Category
- Medical Device — Software
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)
- Connect App version 2.1.6.3 when used with Android OS 8.0 and above.
Distribution
Distributed nationwide across the United States.
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Similar recalls
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FDA (Devices) · 2017-02-01
- HighRoche Recalls Accu-Chek Connect App Due to Bolus Advisor Software Bug
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