Recall Z-2765-2019
Roche Diabetes Care, Inc. · initiated June 12, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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 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.
Codes / lots: 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
Reason for recall
Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).
FDA-determined 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
Details
- Recall number
- Z-2765-2019
- Initiated
- June 12, 2017
- Posted by FDA
- September 30, 2019
- Terminated
- October 30, 2020
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Quantity
- 26,600
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Recalling firm
- Roche Diabetes Care, Inc., Indianapolis, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2766-2019 Class II | Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose…Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or… | 06/12/2017Terminated |