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# Woodside Acquisitions Covid Test Recall is Class 1
- URL: https://www.fdaweb.com/woodside-acquisitions-covid-test-recall-is-class-1/
- Published: 2022-05-18T12:00:00.000Z
- Updated: 2026-09-14T17:45:10.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151837

FDA says the 4/9 Woodside Acquisitions recall of Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) that have not been authorized, cleared, or approved by the agency is Class 1\. An FDA [notice](https://www.fda.gov/medical-devices/medical-device-recalls/woodside-acquisitions-inc-recalls-oral-rapid-sars-cov-2-antigen-rapid-test-kits-and-joysbio-sars-cov?ref=fdaweb.com) says the recall covers 51,240 devices distributed in the U.S. between 1/6 and 1/20.

The notice says the company did not provide FDA with adequate validation data to show that the performance of the tests was accurate, and there is a risk of potential false negative, false positive, or misinterpretation of results.

The company reported receiving no complaints or reports of injuries, deaths, or adverse events.