Facility

DYNEX TECHNOLOGIES, INC.

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

Key facts

2recalls · worst Class II

1inspections · worst VAI

—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)	1117676
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	14340 Sullyfield Cir CHANTILLY, VA, US 20151
Registration status	Active · expires 2026
Parent company	Dynex Technologies, Inc. (owner-operator 10045621)
Brand names	DSX Automated ELISA System; DS2 Automated ELISA System; Agility Automated ELISA System

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (1)

Station, Pipetting And Diluting, For Clinical Use
Product code JQW (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.2750

Recalls & enforcement

Class IIOngoing2025-07-16
The internal label affixed to the sample tip rack is incorrectly labeled as reagent tip racks. When scanned by the Agility instrument, the tip rack is misidentified as a different tip type, rendering it incompatible with the system and preventing use which causes a delay in obtai…
Class IIOngoing2020-07-05
Control samples aspirated from wrong SmartKit on the Agility. Agility software was updated to v1.4.7 to resolve the issue. This leads to a risk that a control from another assay's SmartKit will be used instead of the correct control, which may lead to delayed patient results.

FDA inspections (1)

NAI2022-02-18
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Dynex Technologies, Inc.

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. “DYNEX TECHNOLOGIES, INC. (FEI 1117676) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1117676-dynex-technologies-inc/

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