(Reuters) – Empowered Diagnostics LLC is recalling its COVID-19 exams as they haven’t been cleared to be used in america and will doubtlessly result in false outcomes, the U.S. Meals and Drug Administration (FDA) mentioned on Friday.
The regulator has labeled the recall of the CovClear COVID-19 speedy antigen take a look at and the ImmunoPass COVID-19 neutralizing antibody speedy take a look at as Class 1, or probably the most critical sort of recall.
It cautioned individuals to cease utilizing the 2 exams, which have been distributed with labeling that incorrectly signifies that they’re approved by the FDA.
The corporate couldn’t be instantly reached for remark.
Empowered Diagnostics initiated the recall in December and has pulled again a minimum of 284,575 antigen exams and a couple of,100 antibody exams in america, in line with the regulator.
The CovClear take a look at is presently approved in Canada and the European Union, in line with the corporate’s web site.
(Reporting by Amruta Khandekar; Enhancing by Devika Syamnath)
Supply: KFGO
