Recall Z-0822-05 ยท NBW System, Test, Blood Glucose, Over The Counter
Lifescan Inc
LifeScan brand OneTouch FastTake Blood Glucose Meter
| Date | May 17, 2005 (initiated Apr 11, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| 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 Meter and November 30, 2001 for InDuo Blood Glucose Meter.*** The total number of quantities shippe |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024194 | ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS Lifescan, Inc., Feb 7, 2003 |