—#47067

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 501clinical 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 I90, I93 and I95 (alpha I and two digits)

Why it was recalled

Expired product (dated 2006.06) was shipped as replacement for recalled product.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified by phone and sent a recall letter dated 7/21/06 via fax, which instructed them to discontinue use of these lots of product and to discard them.

Recalling firm

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

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2006-07-21
Posted by FDA: 2006-08-29
Terminated: 2006-11-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #47067. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.