LifeScan brand OneTouch Ultra Test strips, 25 strips per vial
FDA device recall Z-0273-06 · posted 2005-12-08 · Terminated
Recall details
- Recalling firm
- Lifescan Inc
- Reason for recall
- Vials of OneTouch Ultra Test Strips marked with quantities of 25 per vial actually contain only 10 strips.
- Action taken
- The firm has issued a letter to distributors, along with a Pass-along letter for notifying sub-distribution consignees, as well as letters for end users and a notification letter on its website.
- Root cause
- Other
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 5799 vials
- Distribution
- Product was distributed to 9 consignees in NY, KY, MO, AL, TN, LA and IL.
- Date initiated
- 2005-10-19
- Date posted
- 2005-12-08
- Date terminated
- 2006-07-05
- 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 |
|---|---|---|
| ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM (K043197) | Lifescan, Inc. | 2005-05-20 |