Recall Z-0625-2018— Roche Diabetes Care, Inc.
Class II · Terminated
Class II FDA medical device recall by Roche Diabetes Care, Inc., initiated 2017-06-08, terminated 2018-07-27. It names one FDA 510(k) clearance: K150910. Product: Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017. Reason: 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..
- Recalling firm
- Roche Diabetes Care, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-08
- Terminated
- 2018-07-27
- Firm location
- Indianapolis, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.