WASHINGTON — An at-home COVID-19 testing kit is being recalled for failing to meet FDA requirements.
According to a press release from the FDA, SD Biosensor is recalling its STANDARD Q COVID-19 Ag Home Tests because they were distributed to U.S. customers without authorization, clearance, or approval from the FDA. The recall does not apply to the SD Biosensor COVID-19 At-Home Test (also an antigen test), which was authorized by the FDA on Dec. 24, 2021, and is distributed by Roche Diagnostics.
The lack of FDA approval means that there is not sufficient data demonstrating that the test's performance is accurate, which means there's a risk of both false-negative and false-positive test results.
A false negative result is when the test does not detect the SARS-CoV-2 virus, but the person is actually infected. A false-positive result occurs when the test says the person has SARS-CoV-2 virus present, but they are not infected.
There have been no reported injuries or adverse health consequences associated with the STANDARD Q test, the FDA said.
The recall adds to a growing list of at-home testing kits that have been pulled from shelves.
Similar to SD Biosensor's, E25Bio COVID-19 Direct Antigen Rapid Tests were recalled because they did not receive FDA authorization. The FDA also indicated that the type of nasal-swab required by these tests could cause injury if done at-home.
Empowered Diagnostics, Ellume, and Celltrion have recalled certain versions of their at-home tests due to a higher-than-average amount of false-positive results.
The FDA has also issued an advisory for Americans to stop using Flowfex's at-home testing units that have the letters "CE" on the front and come in a dark blue box.
LuSys Laboratories' nasal and saliva antigen tests faced recalls because they did not have FDA emergency approval.