LifeScan OneTouch Ultra Primary Care Physician Demo Kits, Blood Glucose Meter
FDA device recall Z-0272-06 · posted 2005-12-08 · Terminated
Recall details
- Recalling firm
- Lifescan Inc
- Reason for recall
- Users may inadvertently change units of measurement on demonstration kits of the OneTouch Ultra Blood Glucose Meters
- Action taken
- A notification letter dated October 10, 2005 was issued to all health care professionals that requested the demo kit.
- Root cause
- Other
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 2843 kits
- Distribution
- Distributed to 2843 total consignees, 2568 HCPs and 275 sales representatives throughout the USA, no foreign distribution
- Date initiated
- 2005-10-10
- Date posted
- 2005-12-08
- Date terminated
- 2006-11-21
- 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 |