BEUDAMED
    FDA Enforcement Class II Terminated

    Eon 300 system includes the following product reference numbers and names: Reference no. 79345 Glucose (GPSL) Reference no. 79450 Uric acid (AUVD) Reference no. 79435 Triglycerides (TGML) Reference no. 79295 Cholesterol (CHVD) Reference no. 79301 Cholesterol HDL (HDLL) Reference no. 79310 Cholesterol, LDL (LDLL)

    Recall: Z-0215-2016 · Reported November 11, 2015

    Enforcement

    Recall Number
    Z-0215-2016
    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

    Eon 300 system includes the following product reference numbers and names: Reference no. 79345 Glucose (GPSL) Reference no. 79450 Uric acid (AUVD) Reference no. 79435 Triglycerides (TGML) Reference no. 79295 Cholesterol (CHVD) Reference no. 79301 Cholesterol HDL (HDLL) Reference no. 79310 Cholesterol, LDL (LDLL)

    Reason

    ELITech clinical Systems reagents based on Trinder reaction used on the Eon 300 instrument system are recalled due to potential drug interference. No complaints were received.

    Code Info

    all lots

    Distribution

    US Nationwide Distribution

    Quantity

    612 total