Not all COVID-19 Tests are Approved by FDA

Warning issued 3/1/22. These tests have not been authorized, cleared or approved by the FDA for distribution or use in the US, and may show false results.

• Celltrion USA Inc’s DiaTrust COVID-19 Ag Rapid Tests (green and white packaging)

• SD Biosensor Inc’s STANDARD Q COVID-19 Ag Home Test (white and magenta box)

• ACON Laboratories’ Flowflex SARS-CoV-2 Antigen Rapid Test (blue packaging)

• All three companies have initiated a recall for these unauthorized tests that were distributed in the US.

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