Recall Z-1737-2017
Agilent Technologies, Inc. · initiated June 17, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: All
Reason for recall
The product was marketed without 510(k) clearance.
FDA-determined 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 Letters advised that the Bond Elut DMS Product was being withdrawn from the market.
Details
- Recall number
- Z-1737-2017
- Initiated
- June 17, 2015
- Terminated
- April 5, 2017
- Product code
- PJC – Newborn Screening Specimen Collection Paper
- Quantity
- 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.
- Recalling firm
- Agilent Technologies, Inc., Santa Clara, CA