Reported Aug 27, 2025 · Ongoing

Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the…

Dynex Technologies, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Dynex Technologies, Inc. · 14340 Sullyfield Cir · Chantilly, VA · 20151-1621

Is this the product you have?

  • Dynex Agility Sample Tips
  • Model Number67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system
Lot codes and dates
  • Model Number67910
  • UDI-DI5060456180072
  • Lot Number863366
Amount recalled
237 units

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:19 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.