Precision Xtra Blood Glucose monitoring system. Individual test meter and test strip kit.
FDA device recall Z-0856-2007 · posted 2007-06-07 · Terminated
Recall details
- Recalling firm
- Abbott Diabetes Care, Inc.
- Reason for recall
- The front button covers may detach from the meter.
- Action taken
- The firm intends to send letters to all customers that have registered their units under the firm's warranty database and the firm's first consignees. In addition, this notification will be placed on the company website, with e-mail and phone contacts as needed. Letter dated March 5, 2007.
- Root cause
- Other
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- approximately 300 lots
- Distribution
- Product was distributed worldwide.
- Date initiated
- 2007-03-05
- Date posted
- 2007-06-07
- Date terminated
- 2008-04-04
- Location
- Alameda, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM (K040814) | Abbott Laboratories | 2004-04-15 |
| PRECISION XCEED DIABETES MONITORING SYSTEM (K033845) | Abbott Laboratories | 2004-01-08 |