FDA: Class I recall of Woodside Acquisitions SARS-CoV-2 antigen rapid test kits

Editor's Note

The Food and Drug Administration (FDA) on May 16 identified the recall of Woodside Acquisitions Inc’s Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) as Class I, the most serious.

The tests are being recalled because they were distributed to US customers without authorization, clearance, or approval from the FDA. The company did not provide the FDA with adequate validation data to show that the performance of these tests is accurate, and there is a risk of false negative, false positive, or misinterpretation of results.

Distribution dates were January 6, 2022, to January 20, 2022.