CLASS II Device recall · Reported 10 May 2017 · FDA Enforcement Report
Accu-Chek Connect Diabetes Management App versions recalled
Roche Diabetes Care is recalling Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and, distributed nationwide in the US. The recall was initiated on 14 Mar 2017 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-1899-2017
- FDA event ID
- 76870
- Recalling firm
- Roche Diabetes Care, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Mar 2017
- FDA classified
- 1 May 2017
- Reported
- 10 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Other Reasons
- Device type
- Medical Software
Timeline
| 14 Mar 2017 | Recall initiated by company | |
| 1 May 2017 | Classified by FDA | +48 days |
| 10 May 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A program error (bug) in the Bolus Advisor feature, which could result in incorrect bolus advice and a potential insulin over-delivery.
Product as listed by the FDA
Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital product available for download direct to customers from the Apple App Store and the Google Play Store. The total number of downloads is not available. The number of unique users for each affected version from the date of initial distribution through 03/23/2017 is noted in 7a. However, some users will have used all three affected versions as they upgraded from version to version when the versions became available and many others will have tried the app and discontinued use. In the last 30 days, 02/22/2017 03/23/2017, there have been 16,781 unique users in the US with 264 of those seeking bolus advice and 19,268 unique users in the rest of world (excluding Canada) with 415 of those users seeking bolus advice.
Where it was distributed
US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, DE, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaine
Questions about this recall
Why was it recalled?
A program error (bug) in the Bolus Advisor feature, which could result in incorrect bolus advice and a potential insulin over-delivery.
Which lots are affected?
Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android
Where was it sold?
US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, DE, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV
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.
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