Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Number: 67910; UDI-DI: 5060456180072; Lot Number: 863366;
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Dynex Technologies, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
Product Codes/Lot Numbers:
Model Number: 67910; UDI-DI: 5060456180072; Lot Number: 863366;
Distribution:
Distributed in: CA, FL, NC, NJ, NY
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2345-2025
Related Recalls
DYNEX Agility, Agility Analyzer, Model No. 67000
Dynex Technologies
Control samples aspirated from wrong SmartKit on the Agility. Agility software was updated to v1.4.7 to resolve the issue. This leads to a risk that a control from another assay's SmartKit will be used instead of the correct control, which may lead to delayed patient results.