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The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

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) use patient samples to detect proteins, called antigens, found on the SARS-CoV-2 virus. The samples are collected using a nasal swab.

Woodside Acquisitions Inc. is recalling these tests because they were distributed to U.S. customers without authorization, clearance, or approval from the FDA. Woodside Acquisitions Inc. 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 potential false negative, false positive, or misinterpretation of results.

If you use the affected product, this may cause serious adverse health consequences or death.

Woodside Acquisitions Inc. has received no complaints or reports of injuries, deaths, or adverse events.

On April 9, 2022, Woodside Acquisitions Inc. sent a Medical Device Recall letter to customers, distributors, and other U.S. consignees requesting them to take the following actions:

Customers were asked to verify receipt and understanding of this recall letter by emailing Woodside Acquisitions Inc at woodsideinc.pa@gmail.com.

Customers with questions about this recall should contact Woodside Acquisitions Inc. at woodsideinc.pa@gmail.com or call 814-218-2804.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices, including suspected false results or injuries from self-swabbed nasopharyngeal or oropharyngeal samples, to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.