FDA warning letter
FDA Tells Testing Firm to Stop Sale of Unauthorized COVID-19 At-Home Kit
The FDA said that Anytime COVID is marketing a test for at-home use that has not received premarket approval or investigation device exemption.
FDA Warns of Potential False Positive Results With Roche Cobas Liat Rapid SARS-CoV-2, Flu Test
The issues may relate to sporadically leaking assay tubes causing an obstructed optical path in the Cobas Liat analyzer or abnormal PCR cycling in the reaction tubes.
FDA Warns Lab Company to Stop Sale of Unauthorized SARS-CoV-2 Collection Kit
The company is currently selling an at-home sample collection kit that hasn't received premarket approval or investigational device exemption from the agency.Â
FDA Sends Warning Letters About Unauthorized SARS-CoV-2 Tests
The FDA letters were sent to two firms advertising an antibody home test being sold on two websites and a stool test for SARS-CoV-2.
FDA Letter Warns About False-Positive Results From Becton Dickinson SARS-CoV-2 Test
The agency said it recommends that clinical laboratory staff and healthcare providers consider any positive result presumptive from the BD SARS-CoV-2 test.