FDA-Device2013-12-04Class II
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.
Roche Diagnostics Operations, Inc.
Hazard
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.
Sold states
Nationwide Distribution.
Affected count
6,595 units
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0385-2014Don't want to check this manually?
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