FDA Medical Device Recalls (openFDA)
Lifescan Inc: LifeScan OneTouch Ultra Test strips, lot number 2528640
- Recall number
- Z-0435-06
- Recalling firm
- Lifescan Inc
- Product
- LifeScan OneTouch Ultra Test strips, lot number 2528640
- Status
- Terminated
- Initiated
- 2005-11-01
- Posted
- 2006-01-24
- Terminated
- 2006-07-26
- Reason
- Product may be defective and may give low inaccurate glucose results.
- Root cause
- Other
- Action
- Recall was initiated in early November. Notifications were sent on November 21, 2005. The firm has also posted recall notices on its website, and Customer Service Scripting will be available to address questions from callers.
- Quantity
- 7321 boxes of 100 count test strips (29338 vials)
- Distribution
- 7 direct consignees (2 wholesale dealers and 5 distributors_ located in CA, PA, IL, WI, MN, SD, OK, CN, MA, MI.
- Lot, serial or model codes
- Lot number 2528640, par tnumber 020-245-07, Expiration date April 2006
- 510(k) numbers
- ["K043197"]
- PMA numbers
- not on file
- Product code
- CGA
- 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