FDA Offers Update on Jiangsu Well Biotech Recall

The FDA issued an update on Jiangsu Well Biotech’s Aug. 22 recall of its COVID-19 Ag Rapid Test, deeming it a Class 1 recall because of the risk of serious injury or death.

The antigen test uses samples collected by nasal, nasopharyngeal or oropharyngeal swab to detect the SARS-CoV-2 virus. The 110,000 affected products were distributed from July 23, 2021 to Jan. 23.

The devices were distributed to U.S. customers without FDA authorization, clearance, or approval, the agency said, adding that, in the absence of adequate validation data to determine the accuracy of the tests, there is a risk of potential false negative, false positive or misinterpretation of results.

No complaints or reports of injuries or deaths have been associated with the recalled tests, the FDA said.