Calay News
The Spanish Agency for Medicines and Health Products (Aemps) has issued an alert after finding bacteria in a number of lots of an antigen test for COVID-19. The Aemps have discovered the presence of Pseudomonas aeruginosa in the extraction solution of four lots of the Rapid COVID-19 Antigen Test (Colloidal Gold)/Saliva Self-Test, manufactured by Anbio (Xiamen) Biotechnology Co., Ltd. (China). The Aemps has immediately withdrawn all lots distributed in Spanish pharmacies and has requested that the manufacturer and the distributors identified in the marketing registration withdraw all lots from the Spanish market. The AEMP has also called on other potential economic agents and citizens who have purchased the product in question to take appropriate voluntary measures to cease marketing and withdraw the product from the Spanish market.
It is important to note that this is not the first case of bacterial contamination in the product. In June 2022, the Aemps had already notified the FDA of the presence of Pseudomonas aeruginosa in three batches of the same product, which led to the withdrawal of the affected batches. However, the appearance of a fourth infected batch has led to the total withdrawal of the product from the Spanish market.
The AEMP has requested the definitive voluntary cessation of the marketing of the product and has asked distributors and citizens who have purchased the product to take appropriate measures to withdraw it from the Spanish market. The withdrawal of the product from the Spanish market is necessary to avoid the potential risk of infection and to ensure the safety of patients and consumers.
