Z-1352-06

Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747, 902, 911,912...

Name: Z-1352-06 Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747, 902, 911,912...
Creator: Roche Diagnostics Corp.
Published: 2006-07-14
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2006-07-14 / Terminated / root cause: design

FDA source

Roche Diagnostics Corp. began a recall of 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... on 2006-07-14. The reason FDA records is "A design change in the electrodes will result in incorrect potassium level results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1352-06
Status: Terminated
Initiated: 2006-07-14
Posted: 2006-08-03
Terminated: 2007-12-04
Recalling firm: Roche Diagnostics GmbH
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.
Product code: CEM Electrode, Ion Specific, Potassium
Reason for recall: A design change in the electrodes will result in incorrect potassium level results.
Root cause tag: design
FDA root cause: Other
Action: A recall letter dated 7/14/06 instructs users to discontinue use of the product and to discard it.
Quantity in commerce: 1970
Distribution: Nationwide.
Product codes and lots: Lots L33 through L50 through L99 and all M series lots.

Product code CEM

K953239Class IBoehringer Mannheim/hitachi 917 AnalyzerBoehringer Mannheim Corp. / cleared 1995-09-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)