LifeScan brand OneTouch Ultra Test strips, 25 strips per vial
FDA Recall Z-0273-06 · Posted 2005-12-08
Recalling FirmLifescan Inc
Recall StatusTerminated
Product CodeNBW
Date Initiated2005-10-19
Date Terminated2006-07-05
Product Quantity5799 vials
Reason for Recall
Vials of OneTouch Ultra Test Strips marked with quantities of 25 per vial actually contain only 10 strips.
Firm 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.
Root Cause
Other
Distribution Pattern
Product was distributed to 9 consignees in NY, KY, MO, AL, TN, LA and IL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.