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U.S. Department of Health and Human Services

Class 2 Device Recall Bond Elut Dried Matrix Spotting (DMS) cards

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  Class 2 Device Recall Bond Elut Dried Matrix Spotting (DMS) cards see related information
Date Initiated by Firm June 17, 2015
Create Date April 05, 2017
Recall Status1 Terminated 3 on April 05, 2017
Recall Number Z-1737-2017
Recall Event ID 76698
Product Classification Newborn screening specimen collection paper - Product Code PJC
Product 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.
Code Information All
Recalling Firm/
Agilent Technologies, Inc.
5301 Stevens Creek Blvd
Santa Clara CA 95051-7201
For Additional Information Contact Rose Romeo
Manufacturer Reason
for Recall
The product was marketed without 510(k) clearance.
FDA Determined
Cause 2
No Marketing Application
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 Letters advised that the Bond Elut DMS Product was being withdrawn from the market.
Quantity in Commerce 364 in total
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.