Over 56,000 Covid antigen rapid tests have been recalled after the US Food and Drug Administration released a statement on Wednesday saying people should not use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tests distributed by Universal Meditech Inc as they were likely to provide "false results."
According to local WPLG news, the kits, manufactured from October 2021 to December 2021, were distributed in January 2022 "without approval by the FDA."
"This test is not authorized, cleared, or approved by the FDA for distribution or use in the United States," the FDA statement read.
Fox News reports "Consumers are told to 'immediately' stop using the recalled product and contact the distributor to return it, according to the notice."
The kits were sent to California and Texas-based distributors and Universal Meditech Inc is making arrangements to accept returns of all the recalled kits.
The FDA's statement was an update to an original recall placed on May 10, 2022 on Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tests distributed by SML Distribution LLC.
According to the CDC, Antigen rapid tests are less reliable PCR-based tests "especially for people who do not have symptoms." PCR tests are nucleic acid amplification tests and are often performed in hospitals or laboratories.
Antigen tests produce results in 15-30 minutes and, according to the CDC, "To best detect infection, a negative antigen test should be repeated at least 48 hours apart."
As Fox reports, no consumer related injuries have been reported from usage of the product.
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