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E25Bio, Inc. recalls E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
Recalled February 16, 2022 · FDA recall Z-0564-2022 · E25Bio
Hazard
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. · FDA Class I
Units
73,300 units
Sold at
US Nationwide distribution in the states of MA, FL, and HI.
Description
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.
Product
E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
Manufacturer(s)
E25Bio, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →