E25Bio COVID-19 Direct Antigen Rapid Test recall — FDA Z-0564-2022
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.
Overview of recall records associated with E25Bio, Inc., including dates, categories and classifications where available.
Classification mix: Class I: 1.
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.
This page summarizes recall records in which the official source identifies E25Bio, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.