Events

Recall of Device Recall Bond Elut Dried Matrix Spotting (DMS) cards

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Agilent Technologies, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76698
  • Event Risk Class
    Class 2
  • Event Number
    Z-1737-2017
  • Event Initiated Date
    2015-06-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153930
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Newborn screening specimen collection paper - Product Code PJC
  • 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 Letters advised that the Bond Elut DMS Product was being withdrawn from the market.

Device

Device Recall Bond Elut Dried Matrix Spotting (DMS) cards
  • Model / Serial
    All
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
    Agilent Technologies, Inc.

Manufacturer

Agilent Technologies, Inc.
  • Manufacturer Address
    Agilent Technologies, Inc., 5301 Stevens Creek Blvd, Santa Clara CA 95051-7201
  • Manufacturer Parent Company (2017)
    Agilent Technologies, Inc.
  • Source
    USFDA