NEW YORK – Woodside Acquisitions has recalled two COVID-19 rapid antigen tests because they were not authorized, cleared, or approved by the US Food and Drug Administration, the FDA said in a notice posted on Monday to its website.
The FDA has classified the recalls of the Woodside Acquisitions Inc Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit and the Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) as Class I recalls, the most serious type of recall.
The company didn't provide the agency with adequate validation data to show the performance of the tests is accurate, and there is a risk of false negative or positive results or misinterpretation of the results, the FDA said. Woodside Acquisitions hasn't received any complaints or reports of injuries, deaths, or adverse events.
On April 9, the firm sent a recall letter to customers and distributors requesting they return unused products to the company or, if the tests were distributed to third parties, to perform a recall from all purchasers.
The recall applies to tests distributed from Jan. 6 to Jan. 20, 2022.