Reported May 10, 2017 · Terminated

Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a…

Roche Diabetes Care, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Roche Diabetes Care, Inc. · 9115 Hague Rd · Indianapolis, IN · 46256-1025

Is this the product you have?

  • Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0
  • for iOS and Android Product UsageThis is a digital product available for download direct to customers from the Apple App Store and the Google Play Store. The total number of downloads is not available. The number of unique users for each affected version from the date of initial distribution through 03/23/2017 is noted in 7a. However, some users will have used all three affected versions as they upgraded from version to version when the versions became available and many others will have tried the app and discontinued use. In the last 30 days, 02/22/2017 03/23/2017, there have been 16,781 unique users in the US with 264 of those seeking bolus advice and 19,268 unique users in the rest of world (excluding Canada) with 415 of those users seeking bolus advice
Lot codes and dates
  • Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android
Amount recalled
64,324

Where it was sold

Why it was recalled

A program error (bug) in the Bolus Advisor feature, which could result in incorrect bolus advice and a potential insulin over-delivery.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 16, 2018 · Data as of Sep 19, 4:45 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.