Recall Z-2345-2025 ยท LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Dynex Technologies, Inc.
Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
| Date | Aug 22, 2025 (initiated Jul 16, 2025) |
| Status | Open, Classified |
| Reason | 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 | 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 or |
| Quantity | 237 units |
| Distribution | Domestic: CA, FL, NC, NJ, NY; |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.