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 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
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.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.
Customers with questions about this recall should contact Customers with questions about this recall should contact sales@wellbioscience.com.
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