| Date Initiated by Firm | March 05, 2007 |
|---|
| Date Posted | June 07, 2007 |
|---|
| Recall Status1 |
Terminated 3 on April 04, 2008 |
| Recall Number | Z-0856-2007 |
|---|
| Recall Event ID |
37538 |
| 510(K)Number | K033845 K040814 |
|---|
| Product Classification |
Blood Glucose monitoring system. Individual test meter and test strip kit. - Product Code NBW
|
| Product | Precision Xtra Blood Glucose monitoring system. Individual test meter and test strip kit. |
|---|
| Code Information |
Other Brand names include: Precision Xceed Blood Glucose Monitoring system, Optium Xceed, Omron, HEA-214, Optium Xido, MediSense Optium, Boots, Optium (includes Medline and Liberty), Kroger, ReliOn, Rite Aid. |
Recalling Firm/
Manufacturer |
Abbott Diabetes Care, Inc.
1360 S Loop Rd
Alameda CA 94502-7000
|
Manufacturer Reason
for Recall | The front button covers may detach from the meter. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | 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. |
|---|
| Quantity in Commerce | approximately 300 lots |
|---|
| Distribution | Product was distributed worldwide. |
|---|
| 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
|
|---|
