FDA-Device2025-08-27Class II
Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
Dynex Technologies, Inc.
Hazard
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.
Sold states
Domestic: CA, FL, NC, NJ, NY;
Affected count
237 units
Manufactured in
14340 Sullyfield Cir, N/A, Chantilly, VA, United States
Products
Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2345-2025Don't want to check this manually?
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