FDA Device

Roche/Hitachi ALT (ALAT/GPT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number 1877470 (11877470216).

Hazard

Rotation of the instrument reagent compartment can cause a bubble to form in the neck of the reagent bottle causing premature liquid level detection and short sampling of the reagent, resulting in falsely low or zero patient results.

What You Should Do

Remedy

Consignees were mailed recall notices dated 8/20/04 and were instructed to either reduce the initial reagent bottle volume prior to use, or to request replacement product.

Products

Roche/Hitachi ALT (ALAT/GPT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number 1877470 (11877470216).
Brand
Roche Diagnostics Corp.
UPC
All lots expiring on or before 11/05.

Units Affected

728 non-expired kits.