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U.S. Department of Health and Human Services

Class 2 Device Recall AccuChek Aviva II Meter

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  Class 2 Device Recall AccuChek Aviva II Meter see related information
Date Initiated by Firm June 12, 2017
Date Posted September 30, 2019
Recall Status1 Terminated 3 on October 30, 2020
Recall Number Z-2765-2019
Recall Event ID 83574
510(K)Number K133862  
Product Classification System, test, blood glucose, over the counter - Product Code NBW
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.
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 
Recalling Firm/
Manufacturer		 Roche Diabetes Care, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
Manufacturer 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 2		 Process change control
Action 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
Quantity in Commerce 26,600
Distribution Worldwide distribution - US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NBW and Original Applicant = ROCHE DIAGNOSTICS CORPORATION
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