FDA warning letter
Top Five Articles on 360Dx Last Week: FDA Warning on Cue Health COVID Test; More
Last week, readers were most interested in a story about a warning not to use a Cue Health test due to an increased risk of false results.
FDA Warns Against Use of Cue Health COVID-19 Tests
The agency said that the firm's SARS-CoV-2 tests for over-the-counter and point-of-care use have an increased risk of false results.
FDA Warns Beckman Coulter About Quality System Issues
An inspection at one of the firm's manufacturing sites found that the company is not in compliance with FDA's quality system regulation.
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.
Jun 30, 2020
FDA Issues Warning Letter to Luminex
Oct 23, 2017
Magellan Dx Broke Federal Laws, FDA Warns
Oct 10, 2017