FDA Provides Update on Celltrion’s Recall of Some Lots of its COVID-19 Test

The FDA has issued on update on Celltrion’s Feb. 28 recall of specific lots of its DiaTrust COVID-19 Ag rapid test, deeming it a Class 1 recall because of the risk of serious injury or death.

The reason for the recall is a high number of false-positive reports and unauthorized shelf life labeling. The 45,500 affected products with the product code 83QKP were distributed from June 2 to Dec. 21, 2021.

The FDA says that although it has not received any reports of injuries, adverse health consequences or death due to use of the affected test kits, “false-positive or false-negative results from improper use of these tests could lead to further exposure of uninfected individuals to the SARS-CoV-2 virus.

The agency also noted “serious injury risks if someone who is not trained to collect a nasopharyngeal swab sample attempts to do so.”