COVID-19 Ag rapid tests recalled for false positives and unauthorized shelf life

March 17, 2022

Celltrion USA is recalling the DiaTrust COVID-19 Ag Rapid Test due to a high number of false positive reports for some tests, according to a news release from the FDA.

A false-positive antigen test result may lead to a delay in both the correct diagnosis and treatment for the actual cause of a person's illness. False-positive results could also lead to more spread of the SARS-CoV-2 virus if presumed positive people are housed together.

Additionally, the tests’ labeling includes a shelf life of 18 months. However, the FDA’s emergency use authorization specifies these tests may only be used for 12 months.

The use of the affected product could cause serious adverse health consequences and death.

Although there have been no reports of injuries, adverse health consequences, or death associated with the use of the test, false positive or false negative results from improper use of these tests could lead to further exposure of uninfected individuals to SARS-CoV-2 virus. There are also serious injury risks if someone who is not trained to collect a nasopharyngeal swab sample attempts to do so.

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