FDA Provides Update on Celltrion USA’s Recall of Some of its COVID-19 Tests

The FDA has issued on update on Celltrion USA’s April 4 recall of its point-of-care DiaTrust COVID-19 Ag rapid test kits, deeming it a Class 1 recall because of the risk of serious injury or death.

Up to 311,100 affected products were distributed from December 2021 to February. The reason for the recall is that the test may have been distributed to unauthorized users, the agency said.

The rapid test is intended to detect the presence of SARS-CoV-2, the virus that causes COVID-19, based on nasopharyngeal swab samples — from deep inside the nose to the back of the throat — that healthcare providers collect from patients.  

The agency said that “false-positive or false-negative results from improper use of these tests could lead to further exposure of uninfected individuals.”