ELITech Clinical Systems SAS recalls ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AS

Recalled October 8, 2014 · FDA recall Z-0006-2015 · ELITech Clinical Systems SAS

Hazard

Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality Control (QC) fails before the product expiry is reached. · FDA Class III

Units

878 kits

Sold at

Nationwide Distribution

Description

Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality Control (QC) fails before the product expiry is reached.

Product

ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System. Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

Manufacturer(s)

ELITech Clinical Systems SAS

Made in

France

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →