BEUDAMED
    FDA Recall Terminated

    Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 5022-8226 - Auto DBS Card (LCMS Extraction Sys) 50 pk; A400150 - Bond Elut EMS Card 50/Pk; A400150K - Bond Elut DMS Card BULK 500/pk; A400150SK - Bond Elut DMS Card Starter Kit A42001 - Bond Elut MDS Card Accessory Pack Product Usage: For use in the analysis of dried blood spots and other biological matrices in research applications for drug metabolism pharmacokinetics/ absorption, distribution. metabolism and excretion (DMPK/ ADME) studies.

    Recall: Z-1737-2017 · Initiated June 17, 2015

    Recall

    Recall Number
    Z-1737-2017
    Event Number
    76698
    Firm
    Agilent Technologies, Inc.
    FEI Number
    2916205
    Product Code
    PJC
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    June 17, 2015
    Terminated
    April 5, 2017
    Address
    5301 Stevens Creek Blvd, Santa Clara, CA, 95051-7201

    Description

    Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 5022-8226 - Auto DBS Card (LCMS Extraction Sys) 50 pk; A400150 - Bond Elut EMS Card 50/Pk; A400150K - Bond Elut DMS Card BULK 500/pk; A400150SK - Bond Elut DMS Card Starter Kit A42001 - Bond Elut MDS Card Accessory Pack Product Usage: For use in the analysis of dried blood spots and other biological matrices in research applications for drug metabolism pharmacokinetics/ absorption, distribution. metabolism and excretion (DMPK/ ADME) studies.

    Reason

    The product was marketed without 510(k) clearance.

    Action

    Agilent Technologies Letters via e-mail were sent to customers on June 17, 2015. Letters advised that the Bond Elut DMS Product was being withdrawn from the market.

    Distribution

    US and Australia, Thailand, Great Britain, Germany, Japan, Netherlands, France, Taiwan, Canada, South Africa, China, Slovenia, Spain, Italy, Norway, India, Russia, Finland, Czech Republic, Singapore, Denmark, Korea, Ireland, United Arab Emirates, .Belgium, Switzerland and Sweden.

    Quantity

    364 in total