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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