The Recall Desk
HighFDA (Devices)·Z-0625-2018·Announced 2018-02-21

Roche Recalls Accu-Chek Connect App Due to Bolus Advisor Software Bug

Roche Diabetes Care is recalling the Accu-Chek Connect app because a software bug may cause incorrect unit changes, risking inaccurate blood glucose data or carbohydrate input.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device software) where injury has not yet been reported, fitting the 'High' severity criteria for potential harm without confirmed incidents.

Plain-English summary

Roche Diabetes Care, Inc. is recalling the Accu-Chek Connect Diabetes Management App for iOS and Android. The recall involves specific software versions, including 1.2.0, 1.2.2, 1.2.3, 2.0.0, 2.0.1, and 2.1.0. The affected units are identified by Catalog number 07562462001 / GTIN number 00365702700000 and Catalog number 07250452001 / GTIN number 00365702700017.

The recall is due to a program error in the Bolus Advisor feature. When the operating system region setting on the phone is changed, the unit of measure within the app may unexpectedly change. This creates a risk that the app might not transfer blood glucose results correctly or that the user might not correctly input numerical values for carbohydrates used for bolus advice.

Approximately 67,040 unique users of version 2.1.0 are affected, with distribution across the US Nationwide. Consumers should check their app version and follow instructions from the manufacturer to resolve the issue.

The recalled product

Product
Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017
Manufacturer
Roche Diabetes Care, Inc.
Category
Medical Device — Software
Hazard

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 (6)

  • Software Versions: 1.2.0
  • 1.2.2
  • 1.2.3
  • 2.0.0
  • 2.0.1
  • and 2.1.0

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Roche Diabetes Care, Inc.

See all →

Same hazard · software bug

See all →