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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