NEW YORK — Jiangsu Well Biotech is recalling its COVID-19 Ag Rapid Test Device antigen assay that had been distributed in the US without appropriate authorization, clearance, or approval from the US Food and Drug Administration, the agency said Tuesday.
FDA officials classified the action as a Class I recall, which is the agency's most serious type of recall. Jiangsu Well Biotech started the recall Aug. 22 for 110,000 devices that were distributed in the US from July 23, 2021, to Jan. 23, 2022.
The assay was intended for use by healthcare professions to collect nasal, nasopharyngeal, or oropharyngeal swab samples and detect the SARS-CoV-2 virus.
The FDA said the firm distributed the tests without giving the FDA adequate validation data to show the test performance is accurate, meaning use of the devices risks false negative, false positive, or misinterpreted results. The agency also said users risk injury during self-collection of nasopharyngeal or oropharyngeal samples for detection of the SARS-CoV-2 virus.
The agency has received no complaints or reports of injuries or deaths.