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

Recall Z-0625-2018 — Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017

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-0625-2018
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. 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.