Recall Z-1737-2017— Agilent Technologies, Inc.
Class II · Terminated
Class II FDA medical device recall by Agilent Technologies, Inc., initiated 2015-06-17, terminated 2017-04-05. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The product was marketed without 510(k) clearance..
- Recalling firm
- Agilent Technologies, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-17
- Terminated
- 2017-04-05
- Firm location
- Santa Clara, CA, United States
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.
Reason for recall
The product was marketed without 510(k) clearance.
Data sourced from openFDA. This site is unofficial and independent of the FDA.