Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with th
Summary
The FDA issued a Class II for Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips by Dynex Technologies, Inc.. Reason: 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.
Details
Source
Device Recall
External ID
Z-2345-2025
Action Date
2025-08-27
Status
Ongoing
Category
device
Product Description
Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
Lot/Code Info: Model Number: 67910; UDI-DI: 5060456180072; Lot Number: 863366;
Quantity Affected: 237 units
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;
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-16
Company
Chantilly, VA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 135 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Dynex Technologies, Inc. has 3 FDA actions in our database, including 2 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Dynex Technologies, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Dynex Technologies, Inc. have FDA actions?
Dynex Technologies, Inc. has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2345-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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