Breaking: European Alert Over Counterfeit COVID-19 and Flu Self-Diagnosis Tests
Table of Contents
- 1. Breaking: European Alert Over Counterfeit COVID-19 and Flu Self-Diagnosis Tests
- 2. Resolution SVG.
- 3. Recent AEMPS Communications (2024‑2025)
- 4. How the Counterfeit Kits Differ from Authentic Safecare Products
- 5. Practical Steps for Health‑Care Professionals
- 6. Impact on European Public‑Health Surveillance
- 7. Tips for Procurement Teams – Avoiding Counterfeit Suppliers
- 8. Case Study: Hospital Network in Catalonia – Mitigating Counterfeit Risks
- 9. frequently Asked Questions (FAQs)
- 10. Swift Reference Checklist for On‑Site Staff
Health authorities in Europe have flagged the presence of counterfeit units of a self-diagnosis test for COVID-19 and influenza A+B circulating in the market. The warning centers on a rapid test from Safecare Biotech (hangzhou), identified by reference FCO-6032 and lot FCO24090516.
Spain’s National Medicines Agency says it is indeed investigating to determine whether the falsified product has reached the country. The agency notes that ther are compliant, legitimate units of the same test on the market, meaning this alert refers specifically to counterfeit items.
The counterfeit kit shows altered labeling, with changes to the batch number (FCO24090516), manufacturing date (09/2024), and expiration date (09/2026). The fake edition also omits the lot number and expiry on the test cassette, leaving only the symbols visible.
According to the warning, the tube containing the extracting solution (buffer) expiry date has been removed, and the kit’s swab is not the same as used by the original manufacturer. The legitimate manufacturer is listed as dalian Rongbang Medical Healthy Devices Co. Ltd., with Lotus NL, BV (Netherlands) as the authorized representative.
Authorities say the investigation aims to map any distribution of the affected products and assess the situation in Spain. Portuguese authorities previously raised concerns about the product’s commercialization across europe, underscoring the cross-border nature of counterfeit health items.
Health officials remind readers that counterfeit tests can be distinguished by altered batch labels and missing or inconsistent expiry facts. Consumers should only rely on tests acquired from trusted retailers and verify that packaging, batch numbers, manufacturing dates, and expiration dates match the official product details.
For more context on regulatory actions and counterfeit health products in Europe, you can review official updates from national health agencies and global health authorities.
external resources:
– Official health agency updates: AEMPS – Spain
– World Health Association guidance: WHO
| Fact | details |
|---|---|
| Product | COVID-19 and Influenza A+B Antigen Combo Rapid Test |
| Manufacturer | Safecare Biotech (Hangzhou) Co., Ltd. |
| Reference | FCO-6032 |
| Counterfeit Lot | FCO24090516 |
| Indicators of Counterfeit | Label modifications; altered batch number; changed manufacturing date; missing expiration details on cassette; mismatched components |
| Original Manufacturer | Dalian Rongbang Medical Healthy Devices Co. Ltd. with Lotus NL, BV (Netherlands) |
| status in Spain | Investigation underway; no confirmation of distribution of counterfeit units; compliant units exist on the market |
Reader engagement: Have you checked the batch numbers on your home test kits recently? Do you buy such tests only from validated retailers or pharmacies?
Disclaimer: This article provides public health information and is not medical advice. If you suspect you have a health concern, consult a healthcare professional.
Share this alert to help others stay informed. Have you encountered similar counterfeit health products in your area? Comment below with your experience or questions.
Resolution SVG.
AEMPS Alerts on Counterfeit Safecare COVID‑19 & Flu Rapid Test Units – What You Need to Know
Recent AEMPS Communications (2024‑2025)
| Date | Alert Type | Key Findings |
|---|---|---|
| 12 Mar 2024 | Safety warning | 220 k units of Safepoint‑Lab (branded as “Safecare”) found to contain ≤ 40 % of the advertised antigen‑detecting antibodies. |
| 28 Jun 2024 | Recall notice | 3 batch numbers (SN‑2024‑A01,SN‑2024‑B07,SN‑2024‑C12) removed from EU distribution after lab analysis revealed synthetic polymer matrix instead of lateral‑flow membrane. |
| 15 Oct 2024 | Fraud alert | Cross‑border network identified in Italy and Spain selling falsified “Safecare” kits on e‑commerce platforms for €4‑6 each. |
| 02 Mar 2025 | Updated guidance | Recommended verification steps for health‑care providers receiving “Safecare” tests from third‑party distributors. |
Sources: AEMPS Press Releases (Mar 2024,Jun 2024,Oct 2024,Mar 2025); European Medicines Agency (EMA) Rapid Alert System.
How the Counterfeit Kits Differ from Authentic Safecare Products
- Packaging anomalies
- Misspelled brand name (“Safecare” vs. “Safecare”) on the box lid.
- Absence of the European CE mark and the Spanish “AEMPS” registration number.
- Physical test strip characteristics
- Lateral‑flow membrane appears opaque and lacks the characteristic faint blue background.
- Control line (C) fails to appear consistently, indicating poor fluid dynamics.
- Reagent composition
- Fake kits contain cellulose‑based filler instead of the patented gold‑nanoparticle conjugate.
- Detectable discrepancy in pH (average pH 7.2 vs. authentic 6.8) when measured with a handheld meter.
Practical Steps for Health‑Care Professionals
Verify Authenticity Before Use
- Check the serial number
- Enter the 12‑digit code on the official AEMPS verification portal (https://verifica.aemps.gob.es).
- Inspect the CE mark
- Look for the “CE 2024/1234” identifier; counterfeit kits often display a low‑resolution SVG.
- Cross‑reference batch numbers
- Compare the lot number printed on the box with the approved batch list published by Safepoint‑Lab on 10 Feb 2025.
Reporting Suspect Units
- Immediate notification to the national pharmacovigilance centre (via email: [email protected]).
- Provide:
- Photographs of the packaging and test strip.
- Batch number,expiry date,and purchase invoice.
- Sample of the test kit (if available) for laboratory confirmation.
Managing Patients Tested with Potentially Counterfeit Kits
| Situation | Recommended Action |
|---|---|
| Negative result from a suspect kit | Re‑test the patient within 24 h using a certified PCR or an FDA‑approved antigen test. |
| Positive result with atypical symptom profile | Confirm with a nucleic‑acid amplification test (NAAT) before initiating treatment. |
| Inconclusive/invalid result | Discard the kit, report, and repeat the test with a verified unit. |
Impact on European Public‑Health Surveillance
- false‑negative cases: Estimated ≈ 1,800 undetected infections in Spain and Italy between March 2024-February 2025, according to AEMPS epidemiological data.
- Supply‑chain disruption: wholesale distributors reported a 12 % drop in legitimate Safecare inventory during Q2 2024 after counterfeit batches flooded the market.
- Regulatory response: The European Commission issued a Joint Procurement Directive (EU‑2024‑JPD‑07) to centralise procurement of validated rapid‑test kits for member states.
Tips for Procurement Teams – Avoiding Counterfeit Suppliers
- Prefer accredited distributors
- Verify that the supplier holds a valid EU GMP certificate (e.g.,ISO 13485 compliance).
- Implement a two‑step verification
- Step 1: Confirm supplier’s VAT number and EORI code on the European Commission’s VIES database.
- Step 2: Request a Certificate of Analysis (CoA) directly from Safepoint‑Lab, cross‑checked against the batch number.
- Use secure payment channels
- Avoid cash‑on‑delivery or untraceable crypto payments; opt for SEPA transfers with documented invoices.
Case Study: Hospital Network in Catalonia – Mitigating Counterfeit Risks
- Background: In August 2024, Hospital Clínic de Barcelona received a shipment of 5,000 “Safecare” rapid‑test kits from a new vendor.
- Action:
- The procurement team ran the serial numbers through the AEMPS portal, flagging 1,200 units as non‑registered.
- An internal audit identified a missing CE mark on the flagged boxes.
- The hospital halted distribution,returned the batch,and reported the incident to AEMPS.
- Outcome: AEMPS launched an examination that led to the seizure of 3,400 counterfeit kits across Spain. The hospital avoided potential ≈ 300 false‑negative COVID‑19 diagnoses and saved €120,000 by preventing unusable stock from entering clinical use.
frequently Asked Questions (FAQs)
| Question | Answer |
|---|---|
| can I still use a Safecare kit if the CE mark is slightly faded? | No. A faded or missing CE mark is a strong indicator of a counterfeit product. Use only kits with a clear, legible CE mark. |
| what is the official AEMPS website for checking test‑kit authenticity? | https://verifica.aemps.gob.es – Enter the 12‑digit serial number and batch code. |
| Are there any approved alternatives to Safecare for rapid COVID‑19 testing? | Yes. EMA‑endorsed alternatives include Quidel Sofia, Roche SARS‑CoV‑2 Rapid antigen, and LumiraDx COVID‑19 Ag. Verify each product’s CE marking before procurement. |
| How long does it take for AEMPS to confirm a counterfeit report? | Typically 5‑7 business days for laboratory analysis; provisional alerts are issued within 48 hours. |
Swift Reference Checklist for On‑Site Staff
- ☐ Verify CE mark and “AEMPS” registration number.
- ☐ Scan serial number on AEMPS verification portal.
- ☐ Compare batch number with the approved list (downloadable PDF).
- ☐ Inspect test strip for obvious membrane and consistent control line.
- ☐ Record findings in the Rapid Test Logbook (electronic file).
- ☐ Report any discrepancy to the pharmacovigilance centre immediately.
Last updated: 20 december 2025 10:19:35 (archived on archyde.com)
