Roche brand Accu-Chek Aviva Retail Distributor Pack; Catalog number 04578198001. (Distributed within the U.S.)
FDA device recall Z-0420-06 · posted 2006-01-24 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Incorrect patient blood glucose test results may be reported due to a software problem.
- Action taken
- Notification letters dated 11/9/05 were issued to Users, Mail Order Distributors, Clinical Trial Sponsors, Pharmacists and Health Care Professionals. Press release issued 1/17/06.
- Root cause
- Other
- Status
- Terminated
- Product code
- LFR
- Distribution
- Nationwide, Belgium, Canada, Germany, Netherlands, Spain and Sweden.
- Date initiated
- 2005-11-09
- Date posted
- 2006-01-24
- Date terminated
- 2007-06-14
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCU-CHEK AVIVA SYSTEM (K043474) | Roche Diagnostics Corp. | 2005-04-27 |