(WKBN) – Celltrion USA recalled specific batches of DiaTrust COVID-19 Ag Rapid Test due to many false-positive reports.
A false-positive antigen test result can lead to a delay in both the correct diagnosis and treatment of the actual cause of a person’s disease. False-positive results can also lead to more spread of the SARS-CoV-2 virus if presumed positive people are housed together.
The labeling of the tests for the affected products also has a shelf life of 18 months. However, the FDA’s emergency use permit specifies that these tests may only be used for 12 months.
Although there have been no reports of injuries, adverse health consequences or deaths associated with the affected products, false-positive or false-negative results from misuse of these tests may lead to further exposure of uninfected persons to the SARS-CoV-2 virus. .
There are also serious risks of injury if a person who is not trained to take a nasopharyngeal swab sample tries to do so.
Celltrion USA recommended stopping the use of the specific tests and returning all unused products.
The FDA urges healthcare professionals and patients to report adverse events or side effects related to the use of these products for the MedWatch Safety Information and Adverse Event Reporting Program.
For more information on this recall, click here.