On Wednesday, the Food and Drug Administration announced that a healthcare company has recalled 45,500 COVID-19 rapid tests due to a “high number of false-positive reports.”
The pharmaceutical company Celltrion USA has recalled 45,500 COVID-19 rapid tests. Celltrion DiaTrust COVID-19 Ag Rapid Test is intended to detect the presence of SARS-CoV-2, the virus that causes COVID-19, based on a nasopharyngeal (deep inside the nose to the back of the throat) swab sample from patients.
More details of this incident from Fox News report:
The Food and Drug Administration announced Wednesday that a healthcare company has recalled 45,500 COVID-19 rapid tests due to a “high number of false positive reports.”
Pharmaceutical company Celltrion USA announced on Feb. 28 it is recalling specific lots of the DiaTrust COVID-19 Ag Rapid Test due to the high number of false-positive reports, an FDA recall webpage read on Wednesday.
The FDA says that a false-positive test result can lead to a delay in “the correct diagnosis and treatment for the actual cause of a person’s illness.”
The COVID-19 rapid tests also displayed a shelf life of 18 months, but the FDA’s emergency use authorization states that the tests can only be used for 12 months.
Individuals and customers who received the effected COVID-19 rapid tests are being told to discontinue use and return the unused products.
“The use of the affected product could cause serious adverse health consequences and death,” the FDA webpage states.
“This means there is a risk of both false-negative and false-positive test results. False negative results are when the test does not detect the SARS-CoV-2 virus but the person is actually infected. False-positive results occur when the test says the person has SARS-CoV-2 virus present, but they are not infected,” the website states.
Sources: The Gateway Pundit, Fox Business, Miami Standard, News Knowledia, FDA