Lifescan Inc LifeScan brand One Touch UltraSmart Meter Owners Booklet AW 060-788-01A; All One Touch UltraSmart Meters shipped with OneTouch UltraSmart Owner''s Booklet AW 060-788-01A are affected by this Field Correction. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Meter labeling (Owner's Booklet and Quick Reference Guide) is incorrect as it indicates that the meter displays the message 'Do you need a snack' for glucose values between 20 and 70 mg/dL; whereas the OneTouch UltraSmart meter displays the message, 'Do you need a snack?' for glucose values from 20 through 59 mg/dL.

Recommended Action

Per FDA guidance

On 6/9/05, the firm initiated the recall and their notification was via letters informing its customers of the corrective action.