Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DYNEX Agility Recalled by Dynex Technologies, Inc. Due to Control samples aspirated from wrong SmartKit on the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Dynex Technologies, Inc. directly.
Affected Products
DYNEX Agility, Agility Analyzer, Model No. 67000
Quantity: 218 units (17 installed with v1.4.3)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Dynex Technologies, Inc.
Dynex Technologies, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report