Empowered Diagnostics LLC recalls ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60

Recall date

December 22, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0481-2022

FDA classification

Class I

Brand / firm

Empowered Diagnostics LLC

Sold / distributed

US Nationwide Distribution

Why it was recalled

COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60