Medical device recalls Moderate risk

Roche Diabetes Care, Inc. recalls Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 072…

Recall date
June 8, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0625-2018
FDA classification
Class II
Brand / firm
Roche Diabetes Care, Inc.
Sold / distributed
US Nationwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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