Reported Dec 28, 2022 · Ongoing
InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA,…
Companion Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Companion Medical, Inc. · 12230 World Trade Dr Ste 100 · San Diego, CA · 92128-3796
Is this the product you have?
- InPen Diabetes Management App, part of the InPen System
- REF
MMT-105ELBLNAMMT-105ELGYNAMMT-105ELPKNAMMT-105ELPKNAMMT-105NNBLNAMMT-105NNGYNAMMT-105NNPKNA
- Lot codes and dates
- InPen Software App for Android, versions 5.6.1.1 and 5.6.2
- with InPen System REF/UDI-DI
MMT-105ELBLNA/10862088000313MMT-105ELGYNA/10862088000320MMT-105ELPKNA/10862088000337MMT-105NNBLNA/10862088000344MMT-105NNGYNA/10862088000351MMT-105NNPKNA/10862088000368
- Amount recalled
- 140
Where it was sold
Why it was recalled
Diabetes management app may crash immediately upon opening, while using the app and/or while app is running in the background, which may lead to inability to use the app. An error message may be displayed indicating the app has stopped or isn't responding. After the crash, a present dose reminder is not displayed, which may lead to delayed insulin therapy and potentially resulting in hyperglycemia.
This product could cause temporary or reversible health problems — stop using it.
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