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.
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.
Who May be Affected
- Distributors of the COVID-19 Ag Rapid Test Device.
- People who were tested for SARS-CoV-2 using the COVID-19 Ag Rapid Test Device.
- Health care providers and other organizations who used the COVID-19 Ag Rapid Test Device.
What to Do
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:
- Immediately stop using and distributing these tests.
- Distributors should forward the recall information to any affected customer accounts who received the product.
- Complete a response form and return it to the firm.
Contact Information
Customers with questions about this recall should contact sales@wellbioscience.com.