Z-2345-2025Class II

Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable...

Name: Z-2345-2025 Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable...
Creator: Dynex Technologies, Inc.
Published: 2025-07-16
License: https://open.fda.gov/license/

Dynex Technologies, Inc. / initiated 2025-07-16 / Open, Classified / root cause: labeling and UDI

FDA source

Dynex Technologies, Inc. began a recall of Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system on 2025-07-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2345-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-16
Posted: 2025-08-22
Recalling firm: Dynex Technologies, Inc.
Product: Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
Product code: LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On July 16, 2025, URGENT FIELD SAFETY NOTICE letters were emailed to customers. Action to Be Taken by the User: - Upon receipt, Quarantine affected devices and return or destroy them. - Customers have been provided a Field Safety Notice Customer Reply Form. Please complete this form, sign it and return to Dynex as soon as possible to acknowledge that you have received this information and have destroyed or returned to Dynex the impacted 67910 Agility Sample Tips Lot 863366. Transmission of this Field Safety Notice This notice needs to be passed on all those who need to be aware within your organisation or to any organisation where the potentially affected devices have been transferred. (As appropriate) Please transfer this notice to other organisations on which this action has an impact. (As appropriate) Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. Please report all device-related incidents to the manufacturer, distributor or local representative, and the national Competent Authority if appropriate, as this provides important feedback..*
Quantity in commerce: 237 units
Distribution: Domestic: CA, FL, NC, NJ, NY;
Product codes and lots: Model Number: 67910; UDI-DI: 5060456180072; Lot Number: 863366;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2345-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2345-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-27	2025-08-21

Product code LXG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)