FDA recall Z-2345-2025

Dynex Technologies, Inc. · Class II · device

Product

Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.

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.

Distribution

Domestic: CA, FL, NC, NJ, NY;

Key facts

Status
Ongoing
Initiation date
2025-07-16
Report date
2025-08-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chantilly, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2345-2025