FDA Medical Device Recalls (openFDA)
Abbott Diabetes Care, Inc.: Precision Xtra Blood Glucose monitoring system. Individual test meter and test strip kit.
- Recall number
- Z-0856-2007
- Recalling firm
- Abbott Diabetes Care, Inc.
- Product
- Precision Xtra Blood Glucose monitoring system. Individual test meter and test strip kit.
- Status
- Terminated
- Initiated
- 2007-03-05
- Posted
- 2007-06-07
- Terminated
- 2008-04-04
- Reason
- The front button covers may detach from the meter.
- Root cause
- Other
- Action
- The firm intends to send letters to all customers that have registered their units under the firm's warranty database and the firm's first consignees. In addition, this notification will be placed on the company website, with e-mail and phone contacts as needed. Letter dated March 5, 2007.
- Quantity
- approximately 300 lots
- Distribution
- Product was distributed worldwide.
- Lot, serial or model codes
- Other Brand names include: Precision Xceed Blood Glucose Monitoring system, Optium Xceed, Omron, HEA-214, Optium Xido, MediSense Optium, Boots, Optium (includes Medline and Liberty), Kroger, ReliOn, Rite Aid.
- 510(k) numbers
- ["K033845","K040814"]
- PMA numbers
- not on file
- Product code
- NBW
- Firm FEI
- 3002803444
- Firm city
- Alameda
- 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