BEUDAMED
    FDA Enforcement Class II 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 · Reported April 12, 2017

    Enforcement

    Recall Number
    Z-1737-2017
    Event ID
    76698
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Agilent Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 12, 2017
    Initiation Date
    June 17, 2015
    Classification Date
    April 5, 2017
    Termination Date
    April 5, 2017
    Address
    5301 Stevens Creek Blvd, N/A, Santa Clara, CA, 95051-7201, United States

    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.

    Code Info

    All

    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