FDA Device

Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. b. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended for self-testing outside the bo

Hazard

Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).

What You Should Do

Remedy

In a Quality Notification dated December 19, 2018, the firm informed its distribution centers of the issue. Contact Centers were provided with updated troubleshooting guides for Aviva II and Performa II meters in August 2018 with instructions for phone solving power issues for meters produced between June 2016 and June 2017. The firm has taken corrective actions to address the issue. Customers should contact Accu-Chek Customer Care line at 1-800-358-4866, Monday through Friday, between the hours of 8:00 am and 8:00 pm Eastern Standard Time

Products

Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whol
Brand
Roche Diabetes Care, Inc.
UPC
Serial numbers between xxx20000000 and xxx23284925, or less than xxx06335297  Updated serial numbers on 10/12/2019: Aviva II: Between XXX20000000 and XXX23284925  Updated 10/18/2019: Aviva II from XXX05000001 to XXX06335297 OR from XXX20000000 to XXX23284925

Units Affected

26,600