FDA: Class I recall of Woodside Acquisitions’ Oral Rapid and Joysbio SARS-CoV-2 Antigen Rapid Test Kits

Editor's Note

The Food and Drug Administration (FDA) on June 9 updated the Class I recall by Woodside Acquisitions Inc of its Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) that are not authorized, cleared, or approved by the FDA.

The FDA says there is not sufficient data showing the tests are accurate, meaning there is a risk of false negative, false positive, or misinterpretation of results. Test samples are collected using a nasal swab.

The company has not received any complaints or reports of injuries, deaths, or adverse events.

Distribution dates were January 6 to January 20, 2022.