CLASS II Device recall · Reported 1 Feb 2017 · FDA Enforcement Report
Accu-Chek Connect Diabetes Management App recalled
Roche Diabetes Care is recalling Accu-Chek Connect Diabetes Management App, distributed nationwide in the US. The recall was initiated on 20 Dec 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1099-2017
- FDA event ID
- 76147
- Recalling firm
- Roche Diabetes Care, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Dec 2016
- FDA classified
- 26 Jan 2017
- Reported
- 1 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 20 Dec 2016 | Recall initiated by company | |
| 26 Jan 2017 | Classified by FDA | +37 days |
| 1 Feb 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
iOS and Android: Under certain conditions the affected app versions may disregard historical bolus data potentially leading to an incorrect bolus insulin recommendation being provided to the user. iOS only: Pairing and using multiple meters with the Accu-Chek Connect app can under rare circumstances cause the bolus advisor to fail to offer a correction bolus recommendation within the eligible time window following a blood glucose measurement (10 15 minutes). Depending on the individual metabolic situation potentially incorrect bolus advice could lead to serious health consequences such as hypoglycemia. Both software issues may also cause the amount of active insulin displayed during the bolus calculation process to be incorrect and should not be used to manually calculate a bolus.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Accu-Chek Connect Diabetes Management App
Where it was distributed
Worldwide Distribution - Nationwide Distribution The Accu-Chek Connect App for iOS is distributed directly to end users via the Apple App Store. The Accu-Chek Connect App for Android is distributed directly to end users via the Google Play App Store.
Questions about this recall
Why was it recalled?
iOS and Android: Under certain conditions the affected app versions may disregard historical bolus data potentially leading to an incorrect bolus insulin recommendation being provided to the user. iOS only: Pairing and using multiple meters with the Accu-Chek Connect app can under rare circumstances cause the bolus advisor to fail to offer a correction bolus recommendation within the eligible time window following a blood glucose measurement (10 15 minutes). Depending on the individual metabolic situation potentially incorrect bolus advice could lead to serious health consequences such as hypoglycemia. Both software issues may also cause the amount of active insulin displayed during the bolus calculation process to be incorrect and should not be used to manually calculate a bolus.
Which lots are affected?
Catalog number 07562462001 / GTIN number 00365702700000 Catalog number 07250452001 / GTIN number 00365702700017
Where was it sold?
Worldwide Distribution - Nationwide Distribution The Accu-Chek Connect App for iOS is distributed directly to end users via the Apple App Store. The Accu-Chek Connect App for Android is distributed directly to end users via the Google Play App Store.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Roche Diabetes Care
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Accu-Chek Guide (SC) Kit -Intended to quantitatively recalled | Roche Diabetes Care | Other | Nationwide |
| Device | CLASS II | RocheDiabetes Care Platform recalled | Roche Diabetes Care | Device Malfunction | Nationwide |
| Device | CLASS II | Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System recalled | Roche Diabetes Care | Labeling Errors | Nationwide |
| Device | CLASS II | Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System recalled | Roche Diabetes Care | Labeling Errors | Nationwide |
| Device | CLASS II | Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System recalled | Roche Diabetes Care | Labeling Errors | Nationwide |
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