LifeScan brand OneTouch Ultra Blood Glucose Meter
FDA device recall Z-0821-05 · posted 2005-05-17 · Terminated
Recall details
- Recalling firm
- Lifescan Inc
- Reason for recall
- User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
- Action taken
- On 4/11/05, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected products and providing instructions on the correction. Owner's booklet: Firm contacted all accounts by letters of 11/21/03, 2/4/2004, 2/17/04 and 2/9-10/2004 providing important information regarding the owner's booklet.
- Root cause
- Other
- Status
- Terminated
- Product code
- NBW
- Distribution
- Distribution of the product is worldwide. ***Distribution in the United States was between January 15, 2001 for OneTouch Ultra Blood Glucose Meter; April 13, 1998 for OneTouch FastTake Blood Glucose M
- Date initiated
- 2005-04-11
- Date posted
- 2005-05-17
- Date terminated
- 2007-01-24
- 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 |
|---|---|---|
| ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS (K024194) | Lifescan, Inc. | 2003-02-07 |