Lifescan Inc LifeScan brand OneTouch Ultra Meter - Owner''s Booklet; Product is manufactured and distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LifeScan brand OneTouch Ultra Meter - Owner''s Booklet; Product is manufactured and distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037
Brand
Lifescan Inc
Lot Codes / Batch Numbers
Includes all System Kits shipped during June 2003 until December 2003
Products Sold
Includes all System Kits shipped during June 2003 until December 2003
Lifescan Inc is recalling LifeScan brand OneTouch Ultra Meter - Owner''s Booklet; Product is manufactured and distributed by L due to LifeScan brand OneTouch Ultra Meter - Owner's Booklets are missing instructions on how to set the Units of Measurement (UOM)--mg/dL versus mmol/L. Thi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
LifeScan brand OneTouch Ultra Meter - Owner's Booklets are missing instructions on how to set the Units of Measurement (UOM)--mg/dL versus mmol/L. This error has the potential to lead to acute hyperglycemic complications if the user fails to realize that 18mg/dL of glucose is equal to 1 (one) mmol/L.
Recommended Action
Per FDA guidance
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 noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026