(WKBN) — Some COVID-19 home and rapid tests have been recalled due to the potential for false-positive results.
Celltrion USA recalled specific lots of the DiaTrust COVID-19 Ag Rapid Test due to many false-positive reports.
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.
The tests’ labeling for the affected products also includes a shelf life of 18 months. However, the FDA’s emergency use authorization specifies 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 improper use of these tests could lead to further exposure of uninfected individuals to the SARS-CoV-2 virus.
There are also serious injury risks if someone who is not trained to collect a nasopharyngeal swab sample tries to do so.
Celltrion USA recommended discontinuing the use of the specific tests and returning all unused products.
The FDA also announced the recall of the SD Biosensor STANDARD Q COVID-19 Ag Home Test. The FDA said these tests are not approved by its agency.
Those with the tests are asked to discard them.
The FDA encourages health professionals and patients to report adverse events or side effects related to the use of these products to the MedWatch Safety Information and Adverse Event Reporting Program.
For more information about this recall, click here.