Covid-19: Chinese antigen test model suspended for unreliability

One of the antigen test models produced by the Chinese company Hangzhou Realy Tech has seen its marketing suspended in France.

The National Medicines Safety Agency (ANSM) withdrew it from the market on Wednesday due to reliability issues.

They can no longer be used "until they are brought into conformity" by the manufacturer, specifies the ANSM in its letter to the company.

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 ”.

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A recall already occurred on seven batches of the company in May

The health products policeman adds that: "In view of these elements and in view of the lack of justification received from the manufacturer concerning these events, we are suspending (...) the importation, the placing on the market, the distribution, advertising and use "of this device" until they are brought into compliance with the regulations ",

"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 a swab, are currently authorized in France.

Along with the PCR test, they are part of the tests accepted to obtain a temporary health pass for people whose vaccination is not yet complete.

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