Spanish Health Agency AEMPS requests withdrawal of antigen test product

AEMPS has requested the withdrawal of a brand of antigen testing kits thought to produce 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.
This product is manufactured by the Chinese pharmaceutical company Genrui Biotech, and the reason given for the request is, “due to a possible increase in results of false positives”.
According to 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”.
In Spain, this particular antigen test was at this moment only being distributed in five companies, in Madrid capital, Getafe, Barcelona, ​​Sevilla, and Asturias.
The AEMPS has also reported that the competent Irish authority (HIPRA) had informed them of their cessation of commercialisation of the Genrui SaRS-CoV-2 antigen testing kits.
They have voluntarily withdrawn the product from the market in Ireland while they continue investigating the alleged complaints about an increase in false positives covid, as reported by 20minutos.es.

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