Recall Z-0273-06 ยท NBW System, Test, Blood Glucose, Over The Counter
Lifescan Inc
LifeScan brand OneTouch Ultra Test strips, 25 strips per vial
| Date | Dec 8, 2005 (initiated Oct 19, 2005) |
| Status | Terminated |
| Reason | Vials of OneTouch Ultra Test Strips marked with quantities of 25 per vial actually contain only 10 strips. |
| Root cause | Other |
| Action | The firm has issued a letter to distributors, along with a Pass-along letter for notifying sub-distribution consignees, as well as letters for end users and a notification letter on its website. |
| Quantity | 5799 vials |
| Distribution | Product was distributed to 9 consignees in NY, KY, MO, AL, TN, LA and IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043197 | ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc., May 20, 2005 |