CLASS II Device recall · Reported 12 Apr 2017 · FDA Enforcement Report

Bond Elut OMS (Dried Matrix Spotting)' Product recalled

Agilent Technologies is recalling Bond Elut OMS (Dried Matrix Spotting)' Product. The recall was initiated on 17 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll

Quantity recalled364 in total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1737-2017
FDA event ID: 76698
Recalling firm: Agilent Technologies, Santa Clara, CA
Classification: Class II
Status: Terminated
Recall initiated: 17 Jun 2015
FDA classified: 5 Apr 2017
Reported: 12 Apr 2017
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

17 Jun 2015	Recall initiated by company
5 Apr 2017	Classified by FDA	+658 days
12 Apr 2017	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The product was marketed without 510(k) clearance.

Product as listed by the FDA

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.

Where it was distributed

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.

Questions about this recall

Why was it recalled?

The product was marketed without 510(k) clearance.

Which lots are affected?

All

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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