OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring systems: a)OneTouch Ultra, b)
FDA device recall Z-1042-2007 · posted 2007-07-13 · Terminated
Recall details
- Recalling firm
- Lifescan Inc
- Reason for recall
- Damaged Vials/Inaccurate test results: a manufacturing equipment problem on one of the packaging lines had the potential to puncture vials, causing a single hole in the side of the vial below the rim. This result of this defect may produce inaccurately high or low blood glucose test results or error message readings.
- Action taken
- March 2007 via letters to consumers and consignees and web postings. The firm has also set up verbal communication plans for customers who contact Lifescan by phone.
- Root cause
- Other
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- ~33 million vials (25 strips per vial in the US, ~19 million worldwide.
- Distribution
- Worldwide; USA, Europe, Middle East, Africa, Latin America and Canada.
- Date initiated
- 2007-03-22
- Date posted
- 2007-07-13
- Date terminated
- 2008-08-15
- 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 |