The Spanish Agency for Medicines and Health Products (AEMPS) has issued a new alert ordering the Cessation of commercialization and withdrawal from the market of a batch of the rapid antigen test for self-diagnosis of Covid-19, ‘Rapid COVID-19 Antigen Test (Colloidal Gold) / Saliva’manufactured by Anbio (Xiamen) Biotechnology Co., Ltd. (China), due to contamination by the bacterium ‘Pseudomonas aeruginosa’.
The AEMPS became aware of this contamination in the batch 2022012101Therefore, I immediately start the actions to find out the distribution of the affected lot and the situation of the product in the Spanish market. As part of the investigation, the Agency has revealed that “it has carried out tests in its own laboratory to verify the microbiological quality of the extraction solution from lot 2022012101, detecting cfu/ml levels above the specifications in microorganism count tests.” total aerobes and total fungi and yeasts, as well as the presence of the bacterium ‘Pseudomonas aeruginosa’”, which can cause lung, urinary tract (kidney and bladder) or bone infections.
⛔️ Cessation of commercialization and withdrawal from the market of the diagnostic test:
➡️ Rapid COVID-19 Antigen Test (Colloidal Gold)/Saliva
‼️ If you have units of this product, do not use themhttps://t.co/gQ8LVHhzwH
— AEMPS (@AEMPSGOB) March 3, 2023
An event that already happened in the past June 27, 2022when the AEMPS published an alert reporting the Cessation of the commercialization of lots 2022012001, 2022011301 and 2022011501 due to the same incident.
Therefore, the AEMPS “has requested the definitive voluntary cessation of the commercialization of the product, as well as the withdrawal of all batches of the product from the Spanish market, both from the manufacturer Anbio (Xiamen) Biotechnology Co., Ltd. (China), and from the distributors identified in the commercialization register”, they reveal from the website of the agency dependent on the Ministry of Health. Likewise, they request “the rest of the possible economic agents who have distributed the product in our country to take the appropriate voluntary measures to cease marketing and withdraw the product from the Spanish market.”
The affected products
The products that have been withdrawn from the market and have been affected by the presence of the bacteria are the batches of the rapid antigen test for self-diagnosis, ‘Rapid COVID-19 Antigen Test (Colloidal Gold)/Saliva’, with reference: A606201.
Finally, the agency recommends that users who have this test in their homes “do not use it” and that they go to the establishment where they purchased it to return it. However, if this test has been used in recent days, the AEMPS reveals that: “If the instructions for use have been followed when performing the test, the risk is minimal.”