Bond Elut OMS — Class II medical device recall Z-1737-2017
Terminated recall by Agilent Technologies, Inc., reported 2017-04-12. The product was marketed without 510(k) clearance.
| Recall number | Z-1737-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Agilent Technologies, Inc., Santa Clara, CA, United States |
| Recall initiated | 2015-06-17 |
| Classified | 2017-04-05 |
| Reported by FDA | 2017-04-12 |
| Terminated | 2017-04-05 |
| Countries outside the US | AE, AU, BE, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, IE, IN, IT, JP, KR, NL, NO, RU, SE, SG, SI, TH, TW, ZA |
| Quantity | 364 in |
| Model numbers | 5022-8226 |
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 for recall
The product was marketed without 510(k) clearance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1737-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.