The Recall Desk
HighFDA (Devices)·Z-0197-2018·Announced 2017-12-13

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

Roche Diabetes Care is recalling the Accu-Chek Connect app because a bug in the Bolus Advisor feature may prevent correction bolus advice from being available for recent glucose readings.

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 medical device software defect that may prevent the availability of insulin dose calculations for recent glucose readings. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and the agency classification is Class II.

Plain-English summary

Roche Diabetes Care, Inc. is recalling the Accu-Chek Connect diabetes management software app for iOS and Android. The recall involves specific software versions, including 1.0.5, 1.0.15, 1.2.0, 1.2.2, 1.2.3, 2.0.0, 2.0.1, 2.1.0, and 2.1.1. The affected products are identified by Catalog numbers 07562462001 and 07250452001, and GTIN numbers 00365702700000 and 00365702700017. The app is indicated as an aid in the treatment of diabetes, providing features for electronic download of blood glucose meters, data storage, and insulin dose calculation via the Bolus Advisor component.

The recall is due to a program error in the Bolus Advisor feature. After a customer pairs a meter with the app for the first time, a rare condition may occur where the countdown timer is not displayed. In these instances, correction bolus advice is not available for the most recent, valid glucose reading. The same blood glucose value may become available for bolus advice calculation at a later time when the countdown timer is displayed.

The affected software was distributed worldwide, including the United States and Canada. The source text does not specify a total number of affected units, though it notes that 1,134 bolus advisor features were used. Consumers using the affected versions of the app should check their software version and follow instructions from Roche Diabetes Care regarding updates or corrections.

The recalled product

Product
Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number 00365702700017 The Accu-Chek Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software pr
Manufacturer
Roche Diabetes Care, Inc.
Category
Medical Device — Software
Hazard
Affected units
1,134

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 (9)

  • Software Versions 1.0.5
  • 1.0.15
  • 1.2.0
  • 1.2.2
  • 1.2.3
  • 2.0.0
  • 2.0.1
  • 2.1.0
  • and 2.1.1 for iOS and Android.

Distribution

Distributed nationwide across the United States.

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