FDA Device

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.

Hazard

A design change in the electrodes will result in incorrect potassium level results.

What You Should Do

Remedy

A recall letter dated 7/14/06 instructs users to discontinue use of the product and to discard it.

Products

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 10825
Brand
Roche Diagnostics Corp.
UPC
Lots L33 through L50 through L99 and all M series lots.

Units Affected

1970