Agilent Technologies, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1737-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 17, 2015

Date Posted: April 12, 2017

Recall Number: Z-1737-2017

Event ID: 76698

Reason for Recall:

The product was marketed without 510(k) clearance.

Status: Terminated

Product Quantity: 364 in total

Code Information:

All

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated