510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Dynex Technologies, Inc.

Chantilly, VA, US

DYNEX TECHNOLOGIES, INC. appears in FDA device records in Chantilly, VA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
3
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Dynex Technologies, Inc. in 2023.

Clearances by year, as a table
510(k) clearance decisions for Dynex Technologies, Inc., by decision year
YearClearances
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K212769DYNEX SmartPLEX MMRV IgG Assay KitOPLSubstantially Equivalent

Registered establishments

FDA registered establishments for Dynex Technologies, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
11176761117676DYNEX TECHNOLOGIES, INC.14340 Sullyfield Cir, CHANTILLY, VA 20151 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2345-2025Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.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.Class IIOpen, Classified
Z-1222-2022DYNEX Agility, Agility Analyzer, Model No. 67000Control 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.Class IIOpen, Classified
Z-1082-04Pipette Sample Tip, Product part #65910, packaged in cardboard cartons containing 4 plastic racks of 108 pipette tips per rack. Pipette tips are accessory component for Dynex Technologies proprietary automated DSX system.An accessory sampling tip for an in vitro diagnostic test instrument may be inadequately sealed and may cause false assay patient results.Terminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain