Agilent Bond Elut OMS Cards Recalled for Lack of FDA Clearance
Agilent Technologies is recalling Bond Elut OMS cards because they were marketed without the required FDA 510(k) clearance.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a regulatory compliance failure (marketing without clearance) rather than a physical defect causing injury. No illnesses or injuries are reported, fitting the criteria for a moderate, precautionary regulatory recall.
Plain-English summary
Agilent Technologies, Inc. is recalling specific Bond Elut OMS (Dried Matrix Spotting) products, including Auto DBS Cards, Bond Elut EMS Cards, and Bond Elut DMS Cards. The recall involves 364 units in total.
The FDA determined that these products were marketed without 510(k) clearance, which is required for medical devices. The products are used in research applications for analyzing dried blood spots and other biological matrices.
The recalled items were distributed in the United States and numerous international locations, including Australia, Thailand, Great Britain, Germany, Japan, and Canada. Users should stop using these products and contact Agilent Technologies for instructions on return or replacement.
The recalled product
- 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 C
- Manufacturer
- Agilent Technologies, Inc.
- Affected units
- 364
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All
Distribution
Distribution scope not specified by the agency.
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