#18,995
In the midst of what is likely to be the worst flu season in years, Spain's Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) is reporting on a new, and potentially harmful, complication; counterfeit influenza/COVID test kits.
In 2013 The Lancet reported that 1/3rd Of Malaria Drugs Are Fake Or Sub-Standard, while two years later - in 2015's The Lancet: WHO Estimates That 50% Of Drugs For Sale Online Are Fake - we looked at a long report on the spectacular growth of fake online prescription drugs.Counterfeit, or adulterated medicines - or fake diagnostic tests - which are usually purchased online, aren't a new problem.
In 2020 our own government repeatedly warned of substandard and unsafe PPEs and hand sanitizers flooding the market during the pandemic (see NIOSH & FDA Updates On Counterfeit N95 Respirators & Hand Sanitizers).
Also 5 years ago, in Interpol Warning On Fake/Counterfeit COVID Vaccines, Interpol issued an Orange Notice on the risks of seeing fake, substandard, or possibly even stolen vaccines offered online or even entering the supply chain.
More recently (2023), in response to more than 300 deaths (mostly in children) across 7 countries, we looked at the WHO's 6th Alert On Contaminated Cough Syrup - manufactured primarily in India -which contained dangerous (even fatal) amounts of diethylene glycol (DEG) and /or ethylene glycol (EG) as contaminants.
Over the past 5 years we've seen repeated reports of fake or counterfeit COVID home diagnostic tests being sold in the United States (see FDA statement).
This week, however, Europe is reporting the arrival of counterfeit combo Flu/COVID home test kits.
First the translated announcement, after which I'll have a brief postscript.
The Spanish Agency for Medicines and Health Products (AEMPS) reports the detection of counterfeit units of the COVID-19 and Influenza A+B Antigen Combo Rapid Test on the European market.
Publication date: December 19, 2025
Category: Medical devices, counterfeit products
Reference: PS, 65/2025The manufacturer Safecare Biotech (Hangzhou) Co., Ltd. has confirmed that the products with reference FCO-6032 have been tampered with and that the batch number FCO24090516 is counterfeit.
The Agency establishes a series of recommendations for action aimed at distributors, pharmacies and users
The Spanish Agency for Medicines and Health Products (AEMPS) has been informed, through the competent Portuguese authority, of the marketing in the European market of counterfeit units of the COVID-19 and Influenza A+B Antigen Combo Rapid Test, manufactured by Safecare Biotech (Hangzhou) Co., Ltd., with reference FCO-6032 and batch number FCO24090516.
According to information provided by the competent Portuguese authority, the manufacturer has confirmed that the product has been tampered with and that the batch number FCO24090516 is fake.
Current situation in Spain
The Spanish Agency for Medicines and Health Products (AEMPS) has launched an investigation to determine the distribution of the affected products and the situation in Spain. At this time, it is unknown whether the counterfeit test has been distributed in the country.
However, it is reported that there are compliant units of the self-diagnostic product COVID-19 and Influenza A+B Antigen Combo Rapid Test from the same manufacturer and with reference FCO-6032 on the market, so this information note only affects the counterfeit product.
Affected products
Counterfeit products can be identified by the following:
- A label with altered information regarding the batch number, manufacturing date, and expiration date has been affixed. The counterfeit product details appearing on the label are as follows:
- Batch number: FCO24090516
- Date of manufacture: 09/2024
- Expiration date: 09/2026
- The batch number and expiry date have been removed from the test cassette included in the kit, so only the symbols appear.
- The expiration 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 product manufacturer. The original swab manufacturer is Dalian Rongbang Medical Healthy Devices Co. Ltd., with its authorized representative Lotus NL, BV (Netherlands).
Information for users
- Check if you have the affected product. If so, do not use it.
- Remember that self-diagnostic tests should only be purchased through pharmacies. This ensures the proper origin, storage, and preservation of the test. Furthermore, only through this channel will the user have access to a pharmacist and their advice.
Information for distributors and pharmacies
- Examine your traceability records and check if you have any units of the affected product. If so, do not distribute them, remove them from sale, and inform the Spanish Agency for Medicines and Health Products (AEMPS) at psdivcontrol@aemps.es , indicating the details of the company that supplied you with the product.
- If you are aware of an incident related to the use of these products, please report it to the AEMPS surveillance system.
Admittedly, counterfeit test kits aren't the most egregious example of fake or adulterated medical products (think: watered down antibiotics, fentanyl laced recreational drugs, or cosmetics laced with heavy metals, etc.), but people do rely on their results to make potentially life-or-death decisions.
While exact numbers are impossible to come by, there are estimates that hundreds of thousands of people are killed each year from fake or adulterated drugs. Serious, albeit non-fatal consequences, are believed even more common.
Substandard and falsified medical products
3 December 2024
Key facts
- Substandard and falsified medical products affect people all around the world.
- At least 1 in 10 medicines in low- and middle-income countries are substandard or falsified.
- Countries spend an estimated US$ 30.5 billion per year on substandard and falsified medical products.
- Substandard and falsified medical products are often sold online or in informal markets.
Sadly, with an Internet increasingly filled with dangerously misleading A.I. generated slop, social media influencers who appear willing to tout any product or trend for the `clicks', and well-funded bad actors who continue to manufacture these credible looking products, we've created an environment where it is all too easy to be fooled.
Caveat Emptor.
