FDA Device

Roche/Hitachi Glucose Hexokinase Reagent for use on the Hitachi Modular System; Catalog # 1929542 (11929542216). In vitro diagnostic.

Hazard

A contaminant will change the pH of the R2 bottle, causing deterioration of the enzyme, and resulting in incorrect or no results being reported.

What You Should Do

Remedy

A recall notification letter dated 4/12/06 was sent to each customer instructing them to discontinue use of this lot of product.

Products

Roche/Hitachi Glucose Hexokinase Reagent for use on the Hitachi Modular System; Catalog # 1929542 (11929542216). In vitro diagnostic.
Brand
Roche Diagnostics Corp.
UPC
Lot 672652; exp. 6/30/2007.

Units Affected

269 kits