Reported Apr 12, 2017 · Terminated

Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 5022-8226 - Auto DBS Card (LCMS Extraction Sys)…

Agilent Technologies, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Agilent Technologies, Inc. · 5301 Stevens Creek Blvd · Santa Clara, CA · 95051-7201

Is this the product you have?

5 of 5 products

Products covered by this recall
#Product as published
1Bond Elut OMS (Dried Matrix Spotting)' Product
2Catalog model numbers: 5022-8226 - Auto DBS Card (LCMS Extraction Sys) 50 pk
3A400150 - Bond Elut EMS Card 50/Pk
4A400150K - Bond Elut DMS Card BULK 500/pk
5A400150SK - 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.
Lot codes and dates
  • All
Amount recalled
364 in total

Why it was recalled

The product was marketed without 510(k) clearance.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 5, 2017 · Data as of Sep 19, 5:30 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.