Recall Z-2753-2019— Roche Diabetes Care, Inc.
Class II · Terminated
Class II FDA medical device recall by Roche Diabetes Care, Inc., initiated 2019-05-03, terminated 2020-10-30. It names one FDA 510(k) clearance: K150910. Product: Accu-Chek Connect Diabetes Management App. Reason: Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App..
- Recalling firm
- Roche Diabetes Care, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-05-03
- Terminated
- 2020-10-30
- 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
Reason for recall
Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App.
Data sourced from openFDA. This site is unofficial and independent of the FDA.