The US Food and Drug Administration (FDA) has issued a recall for two more COVID-19 tests. The agency is urging people to check the rapid tests they have at home as these two new recalls are “the most serious type,” where use could lead to “serious injuries or death.” For the record, no injuries have been reported in the use of the tests. But they do bring out false positives and negatives.
Here’s what you need to know.
Two new recalls have been announced for rapid at-home COVID-19 tests. These are in addition to four other brands that have previously been recalled, including Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Tests and the LuSys Laboratories Antigen Tests and LuSys Laboratories Antibody Tests.
What two COVID-19 tests were recalled?
The more recent recalls from the FDA are the SD Biosensor STANDARD Q COVID-19 Ag Home Test and the Celltrion DiaTrust COVID-19 Ag Rapid Test. These two recalls have been listed as a Class I recall which is prompted when “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
Why were these two COVID-19 tests recalled?
According to the agency, both tests have been recalled because they do not meet the standard set by the FDA. The SD Biosensor STANDARD Q COVID-19 Ag Home Test is a nasal swab test that detects antigens from SARS-CoV-2. The test has not been authorized for use by the FDA which has prompted the recall citing worries of false negatives or false positives.
“False-negative results are when the test does not detect the SARS-CoV-2 virus but the person is actually infected,” the FDA clarifies. “False-positive results occur when the test says the person has SARS-CoV-2 virus present, but they are not infected.”
At this time, there have not been any reports of injuries, adverse consequences, or death associated with the use of this test. According to the FDA release, this recalled test is different from the FDA-authorized SD Biosensor COVID-19 At-Home Test (also an antigen test), which is safe to use.
The Celltrion DiaTrust COVID-19 Ag Rapid Test is also a nasal swab used to detect antigens from the SARS-CoV-2. The reason for its recall is due to a “high number of false-positive reports.” In addition, the labeling on the tests states it has a shelf life of 18 months, however, the emergency use only allows for 12-month shelf life.
What should I do next?
The agency strongly advises that people do not use either SD Biosensor STANDARD Q COVID-19 Ag Home Test or the Celltrion DiaTrust COVID-19 Ag Rapid Test. Anyone who previously tested with either rapid test is urged to speak with their care provider and to throw out the faulty tests.
If you think you had a problem with a SARS-CoV-2 test, whether through a false negative, false positive, or another adverse outcome, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
The agency is also reminding people of the importance of using a rapid home test that has been FDA-approved. These tests have undergone the strict testing process of the FDA and the results have been shown to be reliable for both negatives and positives. More details about the recalls of these two COVID-19 tests can be found on the FDA website.
Additionally, the FDA lists 45 different COVID-19 antibody tests which have been approved for use in the United States.