FDAJanuary 27, 2022device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

e25bio

Recall history

No related federal recalls on record for this brand yet.

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