Lifescan Inc LifeScan brand OneTouch Ultra Blood Glucose Meter Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LifeScan brand OneTouch Ultra Blood Glucose Meter
Brand
Lifescan Inc
Lot Codes / Batch Numbers
ALL CODES: All lot numbers and serial numbers
Products Sold
ALL CODES: All lot numbers and serial numbers
Lifescan Inc is recalling LifeScan brand OneTouch Ultra Blood Glucose Meter due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026