The Spanish Medicines Agency requests the withdrawal of an antigen test from the pharmaceutical company Genrui due to possible false positives
The Spanish Agency for Medicines and Health Products (AEMPS) has requested the cessation of marketing and withdrawal from the market of an antigen test for the detection of SARS-CoV-2 manufactured by the Chinese pharmaceutical company Genrui Biotech "due to a possible increase in results of false positives ".
According to the AEMPS on its website, the Agency has initiated an investigation into this product and "as a precautionary measure, it has required distributors in Spain to voluntarily cease marketing and withdraw the product from the market" .
Until now, in Spain the antigen test was distributed in five companies (in Madrid capital, Getafe, Barcelona, Seville and Asturias).
The AEMPS has also informed that the competent Irish authority (HIPRA) had informed them of the cessation of commercialization and voluntary withdrawal from the market of the Genrui SaRS-CoV-2 antigen test while investigating the alleged increase in false positives covid.