The marketing of an antigen test model from the Chinese company Hangzhou Realy Tech was suspended on Wednesday by the Medicines Agency (ANSM). A decision taken because of reliability problems, “until they are brought into conformity” by the manufacturer.
The ANSM explains that it “received several reports indicating an unexpected proportion of false positive results linked to the use of the Novel Coronavirus (SARS-CoV-2) rapid test Antigen Rapid Test Cassette Swab marketed by the company Hangzhou Realy Tech and cases of migration defect, making it impossible to read the test ”.
A first reminder in May
“In view of these elements and in the face of the lack of justification received from the manufacturer concerning these events, we are suspending (…) the importation, placing on the market, distribution, advertising and use” of this device “until they are brought into conformity with the regulations”, adds the policeman of health products. “The company is also required to recall the batches of these devices and to inform all natural or legal persons likely to hold the products concerned”, he specifies.
Hangzhou Realy Tech had already recalled seven lots of this test model in May due to the same malfunctions. More than a hundred models of rapid antigenic tests on nasopharyngeal swab (via swab) are currently authorized in France.