Class 1 Device Recall One Touch

• Date Initiated by Firm: October 10, 2006
• Date Posted: December 16, 2006
• Recall Status: Terminated on May 29, 2012
• Recall Number: Z-0263-2007
• Recall Event ID: 36663
• Product Classification: Blood Glucose Test Strips - Product Code CGA
• Product: OneTouchBasic/Profile and OneTouch Ultra- Blood Glucose test strips. For use with ONE TOUCH Brand Meters.
• Code Information: OneTouch Ultra, Lots 2691191 and 2691261. OneTouch Basic/Profile, Lot 2615211
• Recalling Firm/ Manufacturer: Milwaukee Notions, Inc; 1006 Vine Street; Union Grove WI 53182
• Manufacturer Reason for Recall: Counterfeit (manufacturer unknown)
• FDA Determined Cause: Other
• Action: Firm started contacting pharmacists beginning 10/10/06. The phone call told the pharmacist that certain lots were identified by LifeScan as counterfeit and not to further distribute. Recontact on 10/27/2006 updated instructions to pharmacists to recall to the ''user/consumer'' level.
• Quantity in Commerce: 1,695
• Distribution: Nationwide distribution ---- including states of IL, KY, MA, MI, MN, NE, OH, PA, SD, and WI.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.