Health withdraws an antigen test that gave false positives



The Spanish Agency for Medicines and Health Products (AEMPS) of the Ministry of Health has issued a surveillance alert to require the cessation of marketing and withdrawal from the market of a self-diagnostic test for the detection of antigens of SARS-CoV-2, from the company Genrui Biotech Inc (China), due to “a possible increase in false positive results“.

The alert has been issued after the competent Irish authority (HPRA) informed the AEMPS of the cessation of marketing and the voluntary withdrawal from the market in their country of said product, called Genrui Sars-Cov-2 Antigen Test Kit, While carry out an investigation due to “a possible increase in false positive results.”

Thus, the AEMPS has also initiated an investigation and as precautionary measuren has required distributors of this product in Spain to voluntarily cease marketing and withdraw the product from the market.

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