The U.S. Food and Drug Administration (FDA) recalled over 56,000 COVID-19 rapid antigen tests on Wednesday for an increased likelihood that they would produce false results.
According to a statement released by the federal health agency last week announcing the recall, Skippack Medical Lab SARS-CoV-2 Rapid Tests by Universal Meditech Inc were likely to produce inaccurate results.
The development is an update from an earlier announcement from May of last year that the tests were never “authorized, cleared, or approved by the FDA for distribution or use in the United States.”
(U.S. Army National Guard photo)
“The FDA is concerned about the risk of false results when using this test because neither SML Distribution LLC, nor Universal Meditech Inc., has provided the FDA with adequate data to show the test works correctly,” the May 2022 statement reads.
“The FDA is updating this Safety Communication to include Universal Meditech Inc. as an additional distributor of the unapproved Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test. These unapproved tests were separately distributed and were not included in the May 2022 communication,” the statement now says.
According to reports, the faulty COVID-19 tests were delivered to distributors in California and Texas, with Universal Meditech Inc planning to receive the totality of the recalled tests.
Unlike PRC tests typically administered in hospitals, which involve a nucleic acid amplification test to deliver results, rapid antigen tests are not as reliable for asymptomatic COVID-19 patients, according to the CDC.
Antigen tests give users results in roughly 30 minutes and should be repeated “at least 48 hours apart” according to government health officials.
In related COVID-19 news, Rep. Nancy Mace last week claimed COVID-19 vaccines have damaged her, slamming former big tech chiefs for censoring medical experts during a House Oversight and Accountability hearing featuring former Twitter executives.
Speaking to Twitter’s former chief legal officer Vijaya Gadde, former deputy general counsel James Baker, and former Trust and Safety head Yoel Roth – all fired by Elon Musk – Mace outlined several medical complications that arose following her second dose of the COVID-19 vaccine, Valiant News reported.
“I, along with many Americans, have long-term effects from COVID,” said the South Carolina Republican. “Not only was I a long hauler, but I have effects from the vaccine. It wasn’t the first shot, but it was the second shot that I now developed asthma that has never gone away since the second shot. I have tremors in my left hand and I have the occasional heart pain that no doctor can explain.”
This news and commentary by Andrew White originally appeared on Valiant News.
