FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic.
- Recall number
- Z-1017-2010
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic.
- Status
- Terminated
- Initiated
- 2009-06-16
- Posted
- 2010-03-08
- Terminated
- 2010-11-30
- Reason
- Incorrect result: patient sample BUN results reported may be higher or lower than actual level.
- Root cause
- Nonconforming Material/Component
- Action
- Siemens issued an Urgent Field Safety Notice dated 6/16/09 to all affected customers instructing them to discontinue use of the Dimension Vista BUN Flex reagent cartridge lot 09061AA.
- Quantity
- 1254 cartons
- Distribution
- Worldwide distribution: USA, Australia, Canada, Germany, Japan, and Korea.
- Lot, serial or model codes
- Lot number 09061AA exp 2010-03-02
- 510(k) numbers
- ["K051087"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- 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