Z-2765-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 9, 2019
- Initiation Date
- June 12, 2017
- Termination Date
- October 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26,600
Product Description
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.
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 Pattern
Worldwide distribution - US Nationwide distribution.
Code Information
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