Recall Z-2766-2019 ยท NBW System, Test, Blood Glucose, Over The Counter
Roche Diabetes Care, Inc.
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.
| Date | Sep 30, 2019 (initiated Jun 12, 2017) |
| Status | Terminated |
| Reason | Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on). |
| Root cause | 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 |
| Distribution | Worldwide distribution - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133862 | ACCU-CHEK AVIVA PLUS SYSTEM Roche Diagnostics Corporation, Apr 29, 2014 |