Reported Apr 12, 2017 · Terminated
Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 5022-8226 - Auto DBS Card (LCMS Extraction Sys)…
Agilent Technologies, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Agilent Technologies, Inc. · 5301 Stevens Creek Blvd · Santa Clara, CA · 95051-7201
Is this the product you have?
5 of 5 products
| # | Product as published |
|---|---|
| 1 | Bond Elut OMS (Dried Matrix Spotting)' Product |
| 2 | Catalog model numbers: 5022-8226 - Auto DBS Card (LCMS Extraction Sys) 50 pk |
| 3 | A400150 - Bond Elut EMS Card 50/Pk |
| 4 | A400150K - Bond Elut DMS Card BULK 500/pk |
| 5 | 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. |
- Lot codes and dates
- All
- Amount recalled
- 364 in total
Why it was recalled
The product was marketed without 510(k) clearance.
This product could cause temporary or reversible health problems — stop using it.
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