03/02/2022: Lab Alert: FDA Says Do Not Use These Unauthorized COVID-19 Tests

CDC's Laboratory Outreach Communication System (LOCS)

Audience: Individuals Performing COVID-19 Testing

Level: Laboratory Alert

On March 1, 2022, the U.S. Food and Drug Administration (FDA) issued three safety communications:

Do Not Use Certain Celltrion DiaTrust COVID-19 Tests

Celltrion DiaTrust

Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests

SD Biosensor Standard Q Ag

Do Not Use Certain ACON Flowflex COVID-19 Tests

ACON Flowflex

FDA is concerned about the risk of false results when using these unauthorized tests.

We encourage you to review these safety communications in detail and share this message widely with your networks.

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The Laboratory Outreach Communication System

Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)

LOCS@cdc.gov

www.cdc.gov/csels/dls/locs

Page last reviewed: March 2, 2022