“The placing on the European market of the Covid-19 Antigen Test Kit (colloidal gold method) antigen tests from the manufacturer Hangzhou Bioer Technology Co., Ltd has been identified. (China) and agent Medical Devices & Drugs S.L. (Spain) bearing undue CE marking, as there is no evidence of compliance with all the legal requirements applicable at European level, including incomplete technical documentation compared to what is established” in community regulations, said the national medicine authority (Infarmed).
According to Infarmed, “in Portugal, no records of these tests were identified but, given that there is free movement of products in the European Economic Area, Infarmed recommends that the aforementioned test is not acquired or used”, adds the note.
Covid-19 test warning
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