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Home 5 Articles 5 FDA Cracks Down on Unauthorized SARS-CoV-2 Rapid Antigen Tests

FDA Cracks Down on Unauthorized SARS-CoV-2 Rapid Antigen Tests

by | Mar 3, 2022 | Articles, News

The FDA continues to sound the warning on unauthorized SARS-CoV-2 rapid antigen tests. On March 1, the agency issued a trio of Safety Communications warning providers and consumers not to use: The Celltrion DiaTrust COVID-19 Ag Rapid Test—the one that comes in a green and white box and has the same name as another test in different packaging that has received authorization; The SD Biosensor Inc. STANDARD Q COVID-19 Ag Home Test; and The ACON Laboratories Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), which comes in a dark blue box, as opposed to the differently packaged ACON Laboratories Flowflex COVID-19 Antigen Home Test, which has received emergency use authorization and isn’t the subject of the FDA warning. Not even three months into the year, the FDA has issued six do-not-use warnings for eight different unauthorized SARS-CoV-2 rapid tests, including assays from LuSys Laboratories, Empowered Diagnostics, and E25Bio. See more on recent recalls in the March 2022 issue of Diagnostic Testing & Emerging Technologies.

Rapid Diagnostic Tests Placed On Vibrant Pink Background

The FDA continues to sound the warning on unauthorized SARS-CoV-2 rapid antigen tests. On March 1, the agency issued a trio of Safety Communications warning providers and consumers not to use:

  • The Celltrion DiaTrust COVID-19 Ag Rapid Test—the one that comes in a green and white box and has the same name as another test in different packaging that has received authorization;
An image of the white and green packaging for the Celltrion DiaTrust COVID-19 Ag Rapid Test

The Celltrion DiaTrust COVID-19 Ag Rapid Test that comes in a green and white box. Image provided by the FDA.

  • The SD Biosensor Inc. STANDARD Q COVID-19 Ag Home Test; and
  • The ACON Laboratories Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), which comes in a dark blue box, as opposed to the differently packaged ACON Laboratories Flowflex COVID-19 Antigen Home Test, which has received emergency use authorization and isn’t the subject of the FDA warning.
An image of the dark blue box for the ACON Laboratories Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) test

The ACON Laboratories Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), which comes in a dark blue box. Image provided by the FDA.

Not even three months into the year, the FDA has issued six do-not-use warnings for eight different unauthorized SARS-CoV-2 rapid tests, including assays from LuSys Laboratories, Empowered Diagnostics, and E25Bio.

See more on recent recalls in the March 2022 issue of Diagnostic Testing & Emerging Technologies.