E25Bio, Inc. recalls E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit

Recall date

January 27, 2022

Source

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

Recall number

Z-0564-2022

FDA classification

Class I

Brand / firm

E25Bio, Inc.

Sold / distributed

US Nationwide distribution in the states of MA, FL, and HI.

Why it was recalled

The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purposes. It was distributed without sufficient directions or controls in place.

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

E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit