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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
Lots L33 through L50 through L99 and all M series lots.
Products Sold
Lots L33 through L50 through L99 and all M series lots.
Roche Diagnostics Corp. is recalling Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747, 902, due to A design change in the electrodes will result in incorrect potassium level results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A design change in the electrodes will result in incorrect potassium level results.
Recommended Action
Per FDA guidance
A recall letter dated 7/14/06 instructs users to discontinue use of the product and to discard it.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026