Z-1737-2017Class II

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

Name: Z-1737-2017 Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 5022-8226 - Auto DBS Card (LCMS...
Creator: Agilent Technologies, Inc.
Published: 2015-06-17
License: https://open.fda.gov/license/

Agilent Technologies, Inc. / initiated 2015-06-17 / Terminated

FDA source

Agilent Technologies, Inc. began a recall of 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... on 2015-06-17. FDA classified it as Class II and gives the reason as "The product was marketed without 510(k) clearance". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1737-2017
Classification: Class II
Status: Terminated
Initiated: 2015-06-17
Posted: 2017-04-05
Terminated: 2017-04-05
Recalling firm: Agilent Technologies, Inc.
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.
Product code: PJC Newborn Screening Specimen Collection Paper
Reason for recall: The product was marketed without 510(k) clearance.
FDA root cause: 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 Letters advised that the Bond Elut DMS Product was being withdrawn from the market.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.
Product codes and lots: All

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1737-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1737-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-05

Product code PJC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)