BEUDAMED
    FDA Recall 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 · Initiated September 22, 2015

    Recall

    Recall Number
    Z-0217-2016
    Event Number
    72322
    Firm
    ELITech Clinical Systems SAS Zone lndustrielle SEES France
    FEI Number
    3007662974
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 22, 2015
    Posted
    November 5, 2015
    Terminated
    March 4, 2016

    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.

    Action

    The firm sent recall letters or Technical Bulletins to US consignees on 9/22/15 via registered mail. Technical Bulletin #1022 (for EON 100 users) Technical Bulletin #2008 (for EON 300 users) Technical Bulletin #5064 (for ENVOY users) Technical Bulletin #3009 (for Selectra users) ELITechGroup is not requesting return of the affected product. The method sheets and package inserts will be updated with the new interference claims. When available, the revised labeling will be provided to the customer for customer's use until the new IFU is included in the product packaging. Consignees are requested to return the Confirmation of Receipt form back to the firm by FAX to 401-642-9001 or send email to [email protected] or send via US Post: Vital Diagnostics, 27 Wellington Rd., Lincoln, Rl. If you have any questions, please contact Vital Diagnostics Technical Support at 1-800-345-2822 or 855-ELITECH

    Distribution

    US Nationwide Distribution

    Quantity

    13455 systems