FDA Recalls Tens of Thousands of False COVID Antigen Tests

Over 56,000 Covid-19 antigen rapid tests have been recalled in the United States due to false results, according to a statement released by the US Food and Drug Administration (FDA) on Wednesday.

The FDA was not provided with “adequate data to show the test works correctly.”

The Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tests were distributed by Universal Meditech Inc and were manufactured from October to December 2021.

The FDA warned that the tests should not be used as they were likely to produce inaccurate results.

According to a local news source, the FDA had not authorized, cleared, or approved the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tests for distribution or use in the US.

The kits were sent to California and Texas-based distributors and were distributed in January 2022 without FDA approval.

The FDA has advised consumers who have purchased the recalled product to “immediately” stop using it and return it to the distributor.

Universal Meditech Inc is currently 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.