Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to
FDA device recall Z-2766-2019 · posted 2019-09-30 · Terminated
Recall details
- Recalling firm
- Roche Diabetes Care, Inc.
- Reason for recall
- Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).
- 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
- Root cause
- Process change control
- Status
- Terminated
- Product code
- NBW
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Date initiated
- 2017-06-12
- Date posted
- 2019-09-30
- Date terminated
- 2020-10-30
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCU-CHEK AVIVA PLUS SYSTEM (K133862) | Roche Diagnostics Corporation | 2014-04-29 |