Is this your brand? Sign in to claim ownership.

DYNEX TECHNOLOGIES, INC.

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Dynex Ds2	62000	EUDAMEDFDA UDI	Class I	Active
Dynex Dsx	65100	EUDAMEDFDA UDI	Class I	Active
Dynex Ds2	62010	EUDAMEDFDA UDI	Class I	Active
Dialisa 2mp	62003	FDA UDI	Class I	Active
DYNEX Agility	67000	EUDAMEDFDA UDI	Class I	Active
DYNEX SmartPLEX MMRV IgG Assay Kit	K212769	FDA 510(k)	Class II	Active

No authorised representatives on record.

Not available yet.

Not available yet.

Not available yet.

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jul 16, 2025	Z-2345-2025	—	open, classified	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 obtaining patient results.
Jul 5, 2020	Z-1222-2022	—	open, classified	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.
Jun 11, 2004	Z-1082-04	—	terminated	An accessory sampling tip for an in vitro diagnostic test instrument may be inadequately sealed and may cause false assay patient results.