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FDA product code QRX · Class 2 · Clinical Chemistry
8
Registered devices
1
Adverse events
2
Recalls
5
510(k) clearances
Devices with this code
Omnipod 5 Starter Kit — Insulet CorporationOmnipod 5 Controller APP — Insulet CorporationOmnipod 5 Controller — Insulet CorporationDexcom Therapeutic Portal — Dexcom, Inc.Dexcom Therapeutic Services — Dexcom, Inc.Omnipod 5 Controller APP — Insulet CorporationOmnipod 5 Controller APP — Insulet CorporationOmnipod 5 Controller APP — Insulet Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-11 | Insulet Corporation | The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying f |
| 2025-05-23 | Insulet Corporation | Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot |
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