They warn of falsified Covid and flu tests

The Spanish Agency for Medicines and Health Productss (AEMPS) has reported on the marketing in the European market of counterfeit units of the Covid-19 self-diagnosis test and Influenza A+B Antigen Combo Rapid Test, manufactured by Safecare Biotech (Hangzhou), with reference FCO-6032 and batch number FCO24090516.

According to the information provided by the Portuguese competent authority, the manufacturer has confirmed that the product has been tampered with and that the batch number FCO24090516 is false.

The AEMPS has initiated the subsequent investigation to know the distribution of the affected products and the situation in Spain. At the moment, it is unknown if the falsified test has been distributed in Spain. However, it is reported that there are compliant units of the product for self-diagnosis COVID-19 and Influenza A+B Antigen Combo Rapid Test on the market from the same manufacturer and with reference FCO-6032, so this information note only affects the counterfeit product.

Counterfeit products can be identified because a label with the information has been attached. modified relative to lot numberthe manufacturing date and the expiration date. The data of the counterfeit product that appears on the labeling is that of the batch number FCO24090516, with a manufacturing date of 09/2024 and an expiration date of 09/2026.

Additionally, the lot number and expiration date have been removed from the test cassette included in the kit, so only the symbols appear. The expiration date on the tube with the buffer solution has also been removed. The swab included in the kit is not the same one used by the original product manufacturer. The manufacturer of the original swab is Dalian Rongbang Medical Healthy Devices with authorized representative Lotus NL, BV (Netherlands).

Information for users

The AEMPS has advised users to check if they have the affected product. “If yes, please do not use it”, duck. Also, remember that self-diagnosis tests should only be purchased through pharmacies. In this way, the proper origin, storage and conservation conditions of the test are guaranteed. “In addition, only through this channel will the user have the intervention of a pharmacist and their advice,” he adds.

For its part, the AEMPS has asked distributors and pharmacies to examine their traceability records and check whether they have units of the affected product. “If yes, do not distribute them, remove them from sale and inform the AEMPS at the management psdivcontrol@aemps.es, indicating the data of the company that supplied the product,” he concludes.