Terminated

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.

FDA Recall Z-0980-05 · Posted 2005-07-13

Recalling FirmLifescan Inc

Recall StatusTerminated

Product CodeNBW

Date Initiated2005-06-09

Date Terminated2006-12-21

Product Quantity584,291 units

Reason for Recall

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.

Firm Action

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

Root Cause

Other

Distribution Pattern

Product was released for distribution to 40,763 consignees worldwide. The firm provided the following distribution information: 124 wholesaler dealers, 224 distributors, 140 retailers and 40,275 consumers/users involved in the recall. The recall product was distributed in all States within the U.S. In addition, OneTouch UltraSmart meter kits with the affected UltraSmart Owner''s Booklets (AW 060-788-01A) have been distributed internationally in Canada, France, Germany, Italy, United Kingdom, Benelux, Sweden, Finland, Norway, Denmark, Spain, Portugal, Switzerland and Austria. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, pharmacists, and patients who received the recalled products.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021819ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEMLifescan, Inc. · 2002-08-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.