FDA Medical Device Recalls (openFDA)
Lifescan Inc: LifeScan brand OneTouch Sure Step- Blood Glucose Monitoring System Test Strips, 50 strips per package, Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037
- Recall number
- Z-0452-2007
- Recalling firm
- Lifescan Inc
- Product
- LifeScan brand OneTouch Sure Step- Blood Glucose Monitoring System Test Strips, 50 strips per package, Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037
- Status
- Terminated
- Initiated
- 2006-09-29
- Posted
- 2007-01-05
- Terminated
- 2007-11-27
- Reason
- Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results.
- Root cause
- Other
- Action
- The firm has issued notification on 9/29/06 to consumers and hospital end users known to the firm and direct accounts that received the recalled product. The firm also posted the notice on the website, and customer service scripting was developed to notify callers.
- Quantity
- 26,398 units (both recall numbers Z-0452/3-2007
- Distribution
- Nationwide to Al, AZ, CA, CN, DE, FL, GA, IL, IN, KT, KY, LA, MA, MD, MI, MN, MS, MO, NE, NJ, NM, and TX.
- Lot, serial or model codes
- Lot number 2627353, part number 020-052-01
- 510(k) numbers
- ["K022724"]
- 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