FDA recall Z-2753-2019

Roche Diabetes Care, Inc. · Class II · device

Product

Accu-Chek Connect Diabetes Management App

Reason for recall

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

Distribution

Nationwide and worldwide usage of the Connect App.

Key facts

Status
Terminated
Initiation date
2019-05-03
Report date
2019-10-02
Termination date
2020-10-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2753-2019