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Recall Observatory FDA recall evidence

Device product

Accu-Chek Connect Diabetes Management App

Z-2753-2019

May 03, 2019

Class II

Product summary

Firm
Roche Diabetes Care, Inc.
Event
Event 83566
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-2753-2019

Official wording

Reason: Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App.

Code information: Connect App version 2.1.6.3 when used with Android OS 8.0 and above.

Distribution pattern: Nationwide and worldwide usage of the Connect App.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App.