CLASS II Device recall · Reported 21 Feb 2018 · FDA Enforcement Report

Accu-Chek Connect Diabetes Management App recalled

Roche Diabetes Care is recalling Accu-Chek Connect Diabetes Management App, distributed nationwide in the US. The recall was initiated on 8 Jun 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware Versions: 1.2.0, 1.2.2, 1.2.3, 2.0.0, 2.0.1, and 2.1.0

Quantity recalled67,040 unique users of version 2.1.0

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0625-2018
FDA event ID: 79001
Recalling firm: Roche Diabetes Care, Indianapolis, IN
Classification: Class II
Status: Terminated
Recall initiated: 8 Jun 2017
FDA classified: 15 Feb 2018
Reported: 21 Feb 2018
Type: Voluntary: Firm initiated
Customers notified by: Other
Reason category: Device Malfunction
Device type: Medical Software

Timeline

8 Jun 2017	Recall initiated by company
15 Feb 2018	Classified by FDA	+252 days
21 Feb 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a software bug, when the OS region of the phone setting is changed, the unit of measure within the app may unexpectedly change. This creates a risk the app might not transfer the blood glucose result or the user might not correctly input numerical values for carbohydrate used for bolus advice.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017

Where it was distributed

US Nationwide

Nationwide

Questions about this recall

Is Accu-Chek Connect Diabetes Management App recalled?

Yes. Roche Diabetes Care recalled Accu-Chek Connect Diabetes Management App on 8 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-0625-2018.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

US Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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