Alert on Counterfeit Self-Testing Kits for COVID-19 and Influenza
The Spanish Agency for Medicines and Health Products (AEMPS) has been notified by Portuguese authorities regarding the circulation of counterfeit self-testing kits that claim to detect both coronavirus and influenza A+B. While the legitimate product is manufactured by Safecare Biotech in Hangzhou, China, the identified counterfeit kits have a batch number of FCO24090516, which the manufacturer has confirmed as fraudulent.
AEMPS is currently investigating the distribution channels within Spain. As of now, there is no evidence that these counterfeit kits have reached pharmacies or distributors nationally. Complicating matters, there are genuine versions of the test with a similar reference number (FCO-6032), making it challenging to differentiate at a glance. Below, you’ll find an image of the test showing the nearly identical external appearance, with just a few noticeable differences.
Identifying Counterfeit Products
To help consumers, authorities have outlined three clear signs that indicate these tests are counterfeit:
- The label on the kit displays altered information, including batch number FCO24090516, a manufacture date of September 2024, and an expiry date of September 2026.
- The test cassette and the extraction solution tube do not have any lot number or dates listed.
- The swab included is not from the legitimate supplier, which is Dalian Rongbang Medical; Lotus NL serves as its European representative.
Officials strongly advise that these testing kits should only be purchased from licensed pharmacies or trusted vendors. Choosing alternatives could lead to concerns regarding the product’s origin, storage conditions, and the absence of professional guidance. If you find any of these counterfeit tests in your home, the recommendation is unequivocal: do not use them.
Counterfeiting medical devices poses a significant risk. These tools play a crucial role in assessing individual and public health, and inaccurate results can lead to undetected infections or inappropriate treatments.
Conclusion
As health safety remains paramount, it is crucial to stay informed about the legitimacy of medical products. Counterfeit self-testing kits not only undermine trust but also endanger health through potential misinformation. Always purchase these items from reputable sources to ensure quality and reliability.
- Beware of counterfeit self-testing kits for COVID-19 and influenza.
- Check labels for altered information and missing lot numbers.
- Purchase tests exclusively from pharmacies for guaranteed quality.
- Do not use any suspected counterfeit tests.

