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Terminated

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.

FDA Recall Z-1737-2017 · Posted None

Recalling FirmAgilent Technologies, Inc.
Recall StatusTerminated
Product CodePJC
Date Initiated2015-06-17
Date Terminated2017-04-05
Product Quantity364 in total

Reason for Recall

The product was marketed without 510(k) clearance.

Firm 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 Letters advised that the Bond Elut DMS Product was being withdrawn from the market.

Root Cause

No Marketing Application

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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