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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 COVID-19 Ag Rapid Test Device uses patient samples collected by nasal, nasopharyngeal, or oropharyngeal swab to detect proteins, called antigens, found on the SARS-CoV-2 virus. These tests are intended to be used by health care professionals.

Jiangsu Well Biotech Co., Ltd. is recalling COVID-19 Ag Rapid Test Devices because they were distributed to U.S. customers without authorization, clearance, or approval from the FDA. The company has not provided the FDA with adequate validation data to show that the test's performance is accurate. This means there is a risk of potential false negative, false positive, or misinterpretation of results.

Use of these tests may cause serious adverse health consequences or death. There is also a risk of injury if users follow any labeling instructions directing self-collection of nasopharyngeal or oropharyngeal samples.

There have been no complaints or reports of injuries or deaths.

On August 22, 2022, Jiangsu Well Biotech Co., Ltd. sent an email to distributors, and other U.S. consignees requesting they take the following actions:

Customers with questions about this recall should contact sales@wellbioscience.com.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.