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.
Recalled Product
- Product Name: COVID-19 Ag Rapid Test Device
- Product Codes: See Recall Database Entry
- Distribution Dates: July 23, 2021 to January 23, 2022
- Devices Recalled in the U.S.: 110,000
- Date Initiated by Firm: August 22, 2022
Devise Use
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.
Reason for Recall
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.