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.
This recall has been terminated (originally issued June 17, 2015).
- Company
- Agilent Technologies, Inc.
- Recall Initiated
- June 17, 2015
- Terminated
- April 5, 2017
- Recall Number
- Z-1737-2017
- Quantity
- 364 in total
- Firm Location
- Santa Clara, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The product was marketed without 510(k) clearance.
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.
Lot / Code Info
All
Root Cause
No Marketing Application
Action Taken
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 Letters advised that the Bond Elut DMS Product was being withdrawn from the market.
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