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.
Check against the official notice below — it lists the full affected range.
Roche Diagnostics Operations, Inc. is recalling the ACCU-CHEK Aviva Combo Blood Glucose Meter due to a software synchronization issue. In rare cases when the Manual Pump option is selected on the meter, users may receive an incorrect bolus advice recommendation that could result in a temporary under delivery of insulin. The recall affects 6,595 units distributed nationwide, including meters with specific lot codes packaged in both English and Spanish versions of the ACCU-CHEK Combo Kit.
The recall notice does not specify a remedy or the actions affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: Nationwide Distribution. Quantity: 6,595 units Lot/code info: 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.