FDA warning letter
FDA Warns Empowered Diagnostics About Unauthorized COVID-19 Tests
The agency said the firm marketed the CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test without proper authorization.
FDA Warns Against Use of E25Bio COVID-19 Antigen Test
The warning is the second in recent weeks issued by the agency for COVID-19 tests that were not authorized for use by consumers.
FDA Warns Magnolia Medical Technologies Over Manufacturing Issues
The issues relate to the company's Steripath Gen 2 blood collection device, which is designed to divert and discard the first few milliliters of blood collected.
Meridian LeadCare Business Undergoes FDA Inspection, Product Recall
The firm's Magellan business originally received a warning letter from the agency in 2017 regarding failure to submit medical device reports.
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.
Jun 30, 2020
FDA Issues Warning Letter to Luminex
Oct 23, 2017
Magellan Dx Broke Federal Laws, FDA Warns
Oct 10, 2017
FDA Issues Warning Letter to Swedish IVD Firm
Jul 27, 2017
Meridian Bio Q3 Revenues Inch Down 1 Percent
May 26, 2017