Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
ImmunoPass Recalled by Empowered Diagnostics LLC Due to COVID test kits were offered for sale and...
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 Empowered Diagnostics LLC directly.
Affected Products
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
Quantity: 2100 units
Why Was This Recalled?
COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Empowered Diagnostics LLC
Empowered Diagnostics LLC 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