Z-0385-2014 Class II Terminated
FDA device recall Z-0385-2014 was initiated by Roche Diagnostics Operations, Inc. on Oct 25, 2013 and is designated Class II. 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… The recall status is terminated (terminated Jan 14, 2015). Affected quantity: 6,595 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 4, 2013
- Initiation Date
- Oct 25, 2013
- Termination Date
- Jan 14, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,595 units
Product Description
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.
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.
Distribution Pattern
Nationwide Distribution.
Code Information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0385-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026