23.02.2026
To the attention of all importers, distributors and users of medical devices
The National Agency for Medicines and Medical Devices of Romania (NAMMDR) has been informed about the marketing within the European Union of counterfeit units of “COVID-19 and Influenza A+B Antigen Combo Rapid Test For Self-testing”, with reference FCO-6032 and batch number FCO24090516, manufactured by Safecare Biotech (Hangzhou) Co., Ltd., China.
According to the information held by the NAMMDR, counterfeit products can be identified by the following elements:
A label containing modified information regarding the batch number, manufacturing date and expiry date has been applied to the packaging, as follows:
– Batch number: FCO24090516
– Manufacturing date: 09/2024
– Expiry date: 09/2026
– The batch number and expiry date have been removed from the test cassette included in the kit, so only the following symbols appear:
– The expiry date has been removed from the tube containing the extraction solution (buffer).
– The swab included in the kit is not the same as the one used by the original manufacturer of the product. The original manufacturer of the swabs is Dalian Rongbang Medical Healthy Devices Co. Ltd., with their authorised representative -Lotus NL, BV (Netherlands).
In addition, another counterfeit batch with number FCO2023020312 was identified in the European Union, while the original batch number is FCO20230203.
If you have come into possession of such medical devices or are aware of distributors who sell such medical devices on Romanian territory, do not use them and notify the National Agency for Medicines and Medical Devices of Romania using the contact details posted on the NAMMDR website.