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
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
