Accu-Chek Performa 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 body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Accu-Chek Aviva Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). c. The Accu-Chek Aviva Plus Test Strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.
- Company
- Roche Diabetes Care, Inc.
- Recall Initiated
- June 12, 2017
- Posted
- September 30, 2019
- Terminated
- October 30, 2020
- Recall Number
- Z-2766-2019
- Firm Location
- Indianapolis, IN
Reason for Recall
Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).
Distribution
Worldwide distribution - US Nationwide distribution.
Lot / Code Info
Serial numbers less than xxx25525056 Updated serial numbers on 10/12/2019: Performa II: Between XXX20000000 and XXX25525056 Updated 10/18/2019: Performa II: from XXX20000000 to XXX25525056
Root Cause
Process change control
Action Taken
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