New COVID-19 home test authorized, another recalled
The Food and Drug Administration yesterday authorized the emergency use of a new over-the-counter COVID-19 antigen test. Unlike most antigen tests for at-home use, the new test does not require serial testing, FDA said. The agency expects the ACON Laboratories Flowflex COVID-19 Home Test to double the nation’s rapid at-home testing capacity over the next several weeks. The manufacturer plans to produce more than 100 million tests per month by year’s end and 200 million per month by February 2022.
In other news, Ellume on Friday recalled certain lots of its rapid at-home COVID-19 antigen test due to an increased chance of false-positive results.
Related News Articles
Headline
The Centers for Disease Control and Prevention will update its immunization schedules for the COVID-19 and chickenpox vaccines to adopt recent recommendations…
Headline
The Food and Drug Administration today issued a request for public comment on a series of questions regarding current approaches to evaluating artificial…
Headline
The Food and Drug Administration yesterday announced that Olympus issued a global recall of its ViziShot 2 FLEX needles manufactured prior to May 12 following…
Headline
The Food and Drug Administration has identified a Class I recall for Mo-Vis BVBA R-net Joysticks due to a firmware error that causes the wheelchair to ignore…
Headline
COVID-19 infections are growing or likely growing in 45 states and not changing in five states, according to the latest data from the Centers for Disease…
Headline
The Food and Drug Administration July 15 announced a recall by Sandoz on certain lots of cefazolin, due to the lots being mislabeled as penicillin G potassium…