Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0273-06

LifeScan brand OneTouch Ultra Test strips, 25 strips per vial

Lifescan, Inc. / initiated 2005-10-19 / Terminated

Lifescan Inc began a recall of LifeScan brand OneTouch Ultra Test strips, 25 strips per vial on . The reason FDA records is "Vials of OneTouch Ultra Test Strips marked with quantities of 25 per vial actually contain only 10 strips". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0273-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Lifescan, Inc.
Product
LifeScan brand OneTouch Ultra Test strips, 25 strips per vial
Product code
NBW System, Test, Blood Glucose, Over The Counter
Reason for recall
Vials of OneTouch Ultra Test Strips marked with quantities of 25 per vial actually contain only 10 strips.
FDA 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 in commerce
5799 vials
Distribution
Product was distributed to 9 consignees in NY, KY, MO, AL, TN, LA and IL.
Product codes and lots
Lot number 2591755, part number 020-245-07