—#46887

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.

FDA product code: CEM — Electrode, Ion Specific, Potassium
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K953239
Affected lot / code info: Lots L33 through L50 through L99 and all M series lots.

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2006-07-14
Posted by FDA: 2006-08-03
Terminated: 2007-12-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #46887. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.