One Touch Ultra Test Strips, Part Number 020-245-32, lot number 2964512, Manufactured by LifeScan Inc., Milpitas, CA.
FDA device recall Z-2639-2010 · posted 2010-10-01 · Terminated
Recall details
- Recalling firm
- Lifescan Inc
- Reason for recall
- One Touch Ultra Test Strip products may actually contain a different product, One Touch Select strips.
- Action taken
- Notification was issued by the firm during the first week of February. This letter asked consignees to share the information with patients, and are asking users to contact the firm and to examine their stock for the recalled product.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 9631 cartons, 4 vials per carton
- Distribution
- Product was distributed to one wholesale dealer and one distributor and 2 medical facilities in CA, OH and PA, as well as the UK.
- Date initiated
- 2010-01-07
- Date posted
- 2010-10-01
- Date terminated
- 2011-03-14
- Location
- Milpitas, 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 ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM (K062195) | Lifescan, Inc. | 2006-08-16 |