WASHINGTON – Jiangsu Well Biotech Co. Ltd. on Wednesday recalled its COVID-19 Ag Rapid Test devices because they were distributed to U.S. customers without authorization, clearance or approval from the U.S. Food and Drug Administration.
According to the recall notice, use of these devices may cause serious injuries or death, and the FDA classified the action as a Class 1 recall, the agency’s most serious variety.
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 virus that causes COVID-19.
As per the recall notice, the devices are intended to be used by health care professionals and were distributed between July 23, 2021, and Jan. 23, 2022.
According to the FDA, China-based Jiangsu Well Biotech has not provided the regulatory agency with “adequate validation data to show that the test’s performance is accurate,” meaning potential false negative, false positive or misinterpreted results are possible.
In addition to posing serious adverse health consequences, including death, the recalled rapid test devices also pose an injury risk should users “follow any labeling instructions directing self-collection of nasopharyngeal or oropharyngeal samples,” the recall stated.
The company has fielded zero reports of injuries or deaths linked to the recall to date.