Jiangsu Well Biotech recalled its COVID-19 rapid antigen tests that were distributed in the U.S. without regulatory authorization, according to a notice from the Food and Drug Administration on Wednesday.
The tests posed a risk to users because they had not received emergency use authorization, clearance or approval, according to 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 agency wrote in the notice.
Additionally, patients could risk injury if they followed instructions to self-collect nasopharyngeal or oropharyngeal samples, the FDA said. So far, there have been no complaints or reports of injuries.
China-based Jiangsu Well Biotech on Aug. 22 began the recall of 110,000 rapid antigen tests that were distributed in the U.S. between July 2021 and January 2022. In October, the FDA labeled the recall as a Class I event, the most severe type of recall.
The FDA has ordered multiple recalls this year of imported COVID-19 tests that had not been authorized for use in the U.S.