FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics Inc: CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
- Recall number
- Z-1545-2014
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Product
- CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
- Status
- Terminated
- Initiated
- 2013-02-26
- Posted
- 2014-05-04
- Terminated
- 2014-05-06
- Reason
- Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.
- Root cause
- Reprocessing Controls
- Action
- On February 26, 2013, a Siemens Field Engineer from Siemens Healthcare visited customer site and disabled the Sample Interference Notes feature on the instrument.
- Quantity
- 1 unit
- Distribution
- US Distribution in the state of: CA.
- Lot, serial or model codes
- Serial Number: 212809
- 510(k) numbers
- K091216
- PMA numbers
- not on file
- Product code
- KQO
- Firm FEI
- 3002637618
- Firm city
- Norwood
- Firm state
- MA
- 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