Ome Care Draws FDA Warning for Unapproved COVID-19 Tests

Mission Viejo, Calif.-based Ome Care has been marketing COVID-19 tests without FDA approval, the agency said in a warning letter sent to the company.

The agency found that the company marketed the Vivera + Omecare Home Specimen Collection Kit, also called the COVx-HT or RT-PCR Test, which was not authorized by the FDA.

The FDA considers unauthorized COVID-19 tests, like any kind of unapproved diagnostic marketed in the U.S., to be adulterated and misbranded.