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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Dynex Agility Sample Tips Recalled for Mislabeling and Result Delays

Agency Publication Date: August 22, 2025
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Summary

Dynex Technologies, Inc. is recalling 237 units of Dynex Agility Sample Tips (Model Number 67910) from lot 863366. The internal label on the sample tip rack is incorrectly marked as a reagent tip rack, which causes the Agility Automated ELISA system to misidentify the tips as an incompatible type. This error prevents the system from functioning and results in a delay in obtaining patient test results.

Risk

The mislabeling causes the instrument to reject the tip rack, leading to an interruption in laboratory workflow and a delay in diagnostic results. These delays can negatively impact patient care and the timing of medical treatments.

What You Should Do

  1. This recall involves Dynex Agility Sample Tips (Model Number 67910) from lot 863366 with UDI-DI 5060456180072.
  2. Identify affected units by checking the lot number and model number printed on the product packaging or the internal label affixed to the tip rack.
  3. Stop using the recalled sample tips immediately.
  4. Contact Dynex Technologies, Inc. or your laboratory equipment distributor to arrange for a return, replacement, or correction of the mislabeled racks.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action

Return, replacement, or correction of mislabeled racks.

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Dynex Agility Sample Tips
Model / REF:
67910
Lot Numbers:
863366
UDI:
5060456180072

An accessory/consumable used with the Agility Automated ELISA system.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97319
Status: Active
Manufacturer: Dynex Technologies, Inc.
Sold By: Laboratory distributors
Manufactured In: United States
Units Affected: 237 units
Distributed To: California, Florida, North Carolina, New Jersey, New York

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.