Facility

Agilent Technologies, Inc

5 recall(s) on record — most severe on record: Class II.

Key facts

5recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	2916205
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	5301 Stevens Creek Blvd Santa Clara, CA, US 95051
Registration status	Active · expires 2026
Parent company	Agilent Technologies, Inc (owner-operator 10038794)
Brand names	Artisan Congo Red Stain Kit

Activity by year

Recalls (5)

Devices registered here (1)

Congo Red
Product code ICH (opens in a new tab) · Class I · Hematology · 21 CFR 864.1850

Recalls & enforcement

Class IIOngoing2025-03-20
DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, Human Reference DNA Female aliquot, affected by a mosaic aberration that may result in Chromosome 12 baseline shift, which may lead to false positive/negative results, res…
Class IIOngoing2024-04-02
There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury.
Class IIIOngoing2022-05-20
Label provided for substrate vail contained incorrect expiration date.
Class IITerminated2018-08-15
When utilizing specific software versions of an LC/MS device, and Batch at a Glance in Compound Table view, a defect occurs when a new sample(s) is inserted. This defect creates a mismatch between the sample name and the column header whereby the sample header will be offset by o…
Class IITerminated2015-06-17
The product was marketed without 510(k) clearance.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Agilent Technologies, Inc (FEI 2916205) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2916205-agilent-technologies-inc/

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