THE Spanish Agency for Medicines and Health Products (Aemps) warned against detection of counterfeit units in the European market of a self-diagnostic test for covid-19 and flu, although at the moment it is not known whether the falsified test was distributed in Spain.
This is the COVID-19 self-diagnostic test and combined rapid influenza A+B antigen testmade by Safecare Biotech (Hangzhou) Co., Ltd.with reference FCO-6032 and batch number FCO24090516. It was the Portuguese authorities who warned against its marketing on the European market, reported the agency dependent on the Ministry of Health. He the manufacturer itself confirmed that the product was manipulated and that the lot number FCO24090516 is false.
THE AEMPS has opened an investigation know the distribution of the products concerned and the situation in Spainwhere at the moment it is not known if the falsified test was distributed. However, the agency reported that There are compliant units on the market of the product for self-diagnosis COVID-19 and Influenza A+B Antigen Combo Rapid Test from the same manufacturer and with the reference FCO-6032, therefore This alert only concerns counterfeit products..
THE counterfeit productsas detailed by AEMPS, can be identified because a label with modified information relating to the batch number (FCO24090516), the date of manufacture (09/2024) and the expiry date (09/2026).
Furthermore, in the lot number and expiration date of fake tests have been removed from the test cassette included in the kit, only the symbols appear; was deleted expiration date of the tube with the extraction solution (buffer) and the swab included in the kit is not the same as that used by the original product manufacturer (Dalian Rongbang Medical Healthy Devices Co. Ltd. with authorized representative Lotus NL, BV (Netherlands).
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