FDA Medical Device Recalls (openFDA)
Lifescan Inc: LifeScan brand OneTouch Ultra Test strips, 25 strips per vial
- Recall number
- Z-0273-06
- Recalling firm
- Lifescan Inc
- Product
- LifeScan brand OneTouch Ultra Test strips, 25 strips per vial
- Status
- Terminated
- Initiated
- 2005-10-19
- Posted
- 2005-12-08
- Terminated
- 2006-07-05
- 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.
- Lot, serial or model codes
- Lot number 2591755, part number 020-245-07
- 510(k) numbers
- ["K043197"]
- PMA numbers
- not on file
- Product code
- NBW
- Firm FEI
- 2939301
- Firm city
- Milpitas
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28