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ARCHIVED - Spanish Medicines Agency withdraws three contaminated batches of antigen tests
The self-diagnosis Covid tests are contaminated with bacteria and have been removed from the market in Spain
The Spanish Agency for Medicines and Health Products (AEMPA) has launched a national alert after three lots of rapid antigen tests used to detect Covid-19 through saliva samples were found to be contaminated by the bacterium Pseudomonas aeruginosa.
The Covid tests are available at a wide range of commercial outlets in Spain and it is still unknown how far the contaminated batches have been distributed, but AEMPS has advised that “it has immediately initiated the consequent investigation to know the distribution of the affected batches and the situation of the product in the Spanish market.”
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The contamination was alerted by the import company Aleu Medical SL and relates to batches: 2022012001, 2022011301 and 2022011501 of self-diagnosis COVID-19 Rapid COVID-19 Antigen Test (Colloidal Gold)/Saliva, with reference A606201. These tests are manufactured by Anbio (Xiamen) Biotechnology Co., Ltd. (China) with authorised representative Lotus NL BV (Netherlands).
AEMPS has ordered the withdrawal of the products from the Spanish market and has asked distributors and pharmacies to remove the affected items from shelves.
The agency has advised customers to check if they have purchased the contaminated PCR tests and to avoid using them.
“If you are aware of any incident related to the use of these products, report it through the NotificaPS portal,” AEMPS has advised.
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Image: Pixaby
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