CLASS II Device recall · Reported 4 Dec 2013 · FDA Enforcement Report
Accu-chek Aviva Combo Blood Glucose Meter recalled
Roche Diagnostics Operations is recalling Accu-chek Aviva Combo Blood Glucose Meter (as a part of the Accu-chek Aviva Combo, distributed nationwide in the US. The recall was initiated on 25 Oct 2013 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-0385-2014
- FDA event ID
- 66605
- Recalling firm
- Roche Diagnostics Operations, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Oct 2013
- FDA classified
- 22 Nov 2013
- Reported
- 4 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 25 Oct 2013 | Recall initiated by company | |
| 22 Nov 2013 | Classified by FDA | +28 days |
| 4 Dec 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a software synchronization issue with the ACCU-CHEK Combo system. In rare cases, when the Manual Pump option is chosen on the ACCU-CHEK Aviva Combo meter, there is a possibility of receiving an incorrect bolus advice recommendation that may cause a temporary under delivery of insulin.
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 Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger.
Where it was distributed
Nationwide Distribution.
Questions about this recall
Is Accu-chek Aviva Combo Blood Glucose Meter (as a part of the Accu-chek Aviva Combo recalled?
Yes. Roche Diagnostics Operations recalled Accu-chek Aviva Combo Blood Glucose Meter (as a part of the Accu-chek Aviva Combo on 25 Oct 2013. The recall is Class II and its status is Terminated. Recall number Z-0385-2014.
Why was it recalled?
There is a software synchronization issue with the ACCU-CHEK Combo system. In rare cases, when the Manual Pump option is chosen on the ACCU-CHEK Aviva Combo meter, there is a possibility of receiving an incorrect bolus advice recommendation that may cause a temporary under delivery of insulin.
Which lots are affected?
AccuChek Aviva Combo meter 05075645005 packaged in Accu-Chek Combo Kit mg US/English version, 05458544001 and Accu-Chek Combo Kit mg US/Spanish version, 05504686001.
Where was it sold?
Nationwide Distribution.
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 21 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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