BEUDAMED
    FDA Enforcement Class III Terminated

    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.

    Recall: Z-0006-2015 · Reported October 8, 2014

    Enforcement

    Recall Number
    Z-0006-2015
    Event ID
    69024
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    ELITech Clinical Systems SAS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 8, 2014
    Initiation Date
    August 11, 2014
    Classification Date
    October 2, 2014
    Termination Date
    December 11, 2014
    Address
    Zone lndustrielle, N/A, SEES, N/A, N/A, France

    Description

    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.

    Reason

    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.

    Code Info

    Lot 4014, Expiration date 07/2015; Lot 4051, Expiration date 09/2015; Lot 4074, Expiration date 11/2015;

    Distribution

    Nationwide Distribution

    Quantity

    878 kits