Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0263-2007

OneTouchBasic/Profile and OneTouch Ultra- Blood Glucose test strips. For use with ONE TOUCH Brand Meters

Milwaukee Notions, Inc / initiated 2006-10-10 / Terminated / root cause: manufacturing process

Milwaukee Notions, Inc began a recall of OneTouchBasic/Profile and OneTouch Ultra- Blood Glucose test strips. For use with ONE TOUCH Brand Meters on . The reason FDA records is "Counterfeit (manufacturer unknown)". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0263-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Milwaukee Notions, Inc
Product
OneTouchBasic/Profile and OneTouch Ultra- Blood Glucose test strips. For use with ONE TOUCH Brand Meters.
Product code
CGA Glucose Oxidase, Glucose
Reason for recall
Counterfeit (manufacturer unknown)
Root cause tag
manufacturing process
FDA root 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.
Product codes and lots
OneTouch Ultra, Lots 2691191 and 2691261.  OneTouch Basic/Profile, Lot 2615211