BEUDAMED
    FDA Enforcement Class II Terminated

    ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following product reference numbers and names: GPSL-025O: Glucose PAP SL AUML-0250: URIC ACID MONO SL CHSL-0250: CHOLESTEROL SL, TGML-0250: TRIGLYCERIDES SL, CRSL-0250: CREATININE PAP SL HDLL-0230: CHOLESTEROL HDL SL 2G LDLL-0230: CHOLESTEROL LDL SL 2G

    Recall: Z-0216-2016 · Reported November 11, 2015

    Enforcement

    Recall Number
    Z-0216-2016
    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

    ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following product reference numbers and names: GPSL-025O: Glucose PAP SL AUML-0250: URIC ACID MONO SL CHSL-0250: CHOLESTEROL SL, TGML-0250: TRIGLYCERIDES SL, CRSL-0250: CREATININE PAP SL HDLL-0230: CHOLESTEROL HDL SL 2G LDLL-0230: CHOLESTEROL LDL SL 2G

    Reason

    ELITech Clinical Systems reagents based on Trinder reaction used on the Selectra ProS and ProM systems are recalled due to potential drug interference. No complaints were received.

    Code Info

    all lots

    Distribution

    US Nationwide Distribution

    Quantity

    969 systems