BEUDAMED
    FDA Enforcement Class II Terminated

    Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT KIT 55435 ENVOY 500 TRIGLYCERIDES REAGENT KIT, 55297 ENVOY 500 CHOLESTEROL REAGENT KIT, 55335 ENVOY 500 CREATININE REAGENT KIT 55301 ENVOY 500 HDL CHOLESTEROL REAGENT 55310 ENVOY 500 LDL CHOLESTEROL REAGENT KIT

    Recall: Z-0217-2016 · Reported November 11, 2015

    Enforcement

    Recall Number
    Z-0217-2016
    Event ID
    72322
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ELITech Clinical Systems SAS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 11, 2015
    Initiation Date
    September 22, 2015
    Classification Date
    November 4, 2015
    Termination Date
    March 4, 2016
    Address
    Zone lndustrielle, N/A, SEES, N/A, N/A, France

    Description

    Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT KIT 55435 ENVOY 500 TRIGLYCERIDES REAGENT KIT, 55297 ENVOY 500 CHOLESTEROL REAGENT KIT, 55335 ENVOY 500 CREATININE REAGENT KIT 55301 ENVOY 500 HDL CHOLESTEROL REAGENT 55310 ENVOY 500 LDL CHOLESTEROL REAGENT KIT

    Reason

    ELITech clinical Systems reagents based on Trinder reaction used on the Envoy 500 instrument system are recalled due to potential drug interference. No complaints were received.

    Code Info

    all lots

    Distribution

    US Nationwide Distribution

    Quantity

    13455 systems