Z-1737-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 12, 2017
- Initiation Date
- June 17, 2015
- Termination Date
- April 5, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 364 in total
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.
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.
Code Information
All