FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747, 902, 911,912, 917, Modular and cobas c 501 clinical chemistry analyzers; Roche Catalog/Part Number 10825441001/ US # 722-4402.
- Recall number
- Z-1352-06
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747, 902, 911,912, 917, Modular and cobas c 501 clinical chemistry analyzers; Roche Catalog/Part Number 10825441001/ US # 722-4402.
- Status
- Terminated
- Initiated
- 2006-07-14
- Posted
- 2006-08-03
- Terminated
- 2007-12-04
- Reason
- A design change in the electrodes will result in incorrect potassium level results.
- Root cause
- Other
- Action
- A recall letter dated 7/14/06 instructs users to discontinue use of the product and to discard it.
- Quantity
- 1970
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lots L33 through L50 through L99 and all M series lots.
- 510(k) numbers
- ["K953239"]
- PMA numbers
- not on file
- Product code
- CEM
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- 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