Recall Z-0980-05 ยท NBW System, Test, Blood Glucose, Over The Counter
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.
| Date | Jul 13, 2005 (initiated Jun 9, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | On 6/9/05, the firm initiated the recall and their notification was via letters informing its customers of the corrective action. |
| Quantity | 584,291 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021819 | ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc., Aug 23, 2002 |