CLASS II Device recall · Reported 2 Oct 2019 · FDA Enforcement Report
Accu-Chek Connect Diabetes Management App recalled
Roche Diabetes Care is recalling Accu-Chek Connect Diabetes Management App, distributed nationwide in the US. The recall was initiated on 3 May 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2753-2019
- FDA event ID
- 83566
- Recalling firm
- Roche Diabetes Care, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 May 2019
- FDA classified
- 26 Sep 2019
- Reported
- 2 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Other Reasons
- Device type
- Medical Software
Timeline
| 3 May 2019 | Recall initiated by company | |
| 26 Sep 2019 | Classified by FDA | +146 days |
| 2 Oct 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App.
Product as listed by the FDA
Accu-Chek Connect Diabetes Management App
Where it was distributed
Nationwide and worldwide usage of the Connect App.
Questions about this recall
Why was it recalled?
Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App.
Which lots are affected?
Connect App version 2.1.6.3 when used with Android OS 8.0 and above.
Where was it sold?
Nationwide and worldwide usage of the Connect App.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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