FDA Provides Update on Woodside Acquisitions’ Recall of Its COVID-19 Tests

The FDA has given a Class I designation, the highest level of risk, to Woodside Acquisitions’ April 9 recall of its Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) because of the potential for serious injury or death if the device should malfunction.

The agency said the tests, which use nasal swab samples to detect the SARS-CoV-2 coronavirus antigens, were not authorized, cleared or approved for distribution in the U.S.

The 51,240 affected products were distributed from Jan. 6 to Jan. 20.

The FDA said it has received no reports of injuries, deaths, or adverse events associated with the recalled tests. The agency has notified numerous companies that their COVID tests were not authorized, prompting recalls.