Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0197-2018 — 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 provides for electroni

U.S. FDA — Device Enforcement · United States · 2017-06-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0197-2018
Date of alert
2017-06-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Roche Diabetes Care, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07562462001
Reported risk: Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. After pairing a meter with the app for the first time, a customer may encounter the rare condition in which the countdown timer is not displayed and correction bolus advice is not available for the most recent, valid glucose reading. This same blood glucose value may become available for bolus advice calculation at a later time (countdown timer is displayed).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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