The marketing of an antigen test model of the Chinese company Hangzhou Realy Tech was suspended Wednesday by the Medicines Agency (ANSM) because of reliability problems, “until they are brought into compliance” by the manufacturer. The ANSM explains having “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 failure, making it impossible to read the test “.
Over a hundred models available in France
“In view of these elements and in view of the lack of justification received from the manufacturer concerning these events, we suspend (…) the importation, the placing on the market, the distribution, the advertising and the use “of this device” until their compliance 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.
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