LifeScan OneTouch Ultra Test strips, lot number 2528640
FDA device recall Z-0435-06 · posted 2006-01-24 · Terminated
Recall details
- Recalling firm
- Lifescan Inc
- Reason for recall
- Product may be defective and may give low inaccurate glucose results.
- Action taken
- Recall was initiated in early November. Notifications were sent on November 21, 2005. The firm has also posted recall notices on its website, and Customer Service Scripting will be available to address questions from callers.
- Root cause
- Other
- Status
- Terminated
- Product code
- CGA
- Quantity affected
- 7321 boxes of 100 count test strips (29338 vials)
- Distribution
- 7 direct consignees (2 wholesale dealers and 5 distributors_ located in CA, PA, IL, WI, MN, SD, OK, CN, MA, MI.
- Date initiated
- 2005-11-01
- Date posted
- 2006-01-24
- Date terminated
- 2006-07-26
- 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 |