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 501clinical chemistry analyzers; Roche Catalog/Part Number 10825441001/ US # 722-4402.

Hazard

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

What You Should Do

Remedy

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.

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 501clinical chemistry analyzers; Roche Catalog/Part Number 108254
Brand
Roche Diagnostics Corp.
UPC
Lots I90, I93 and I95 (alpha I and two digits)

Units Affected

137 electrodes