Products for which conformity documentation could not be confirmed

Dear Customer,

We are contacting you because our records indicate that you have purchased one or more of the following products from us:

7340221708136 — Blood Type Test
7340221700925 — 2-in-1 Trichomoniasis/Gardnerella Test
7340221704770 — 3-in-1 STI Test
7340221704794 — 8-in-1 STI Test
7340221709744 — Chlamydia Test

As part of an internal regulatory review, we could not confirm that all required EU conformity documents were in place for these products at the time of their placement on the market.

After identifying this documentation gap, we immediately stopped the sale and marketing of the affected products. We are now contacting all customers who have received affected units.

The issue concerns the availability and confirmation of the required regulatory documentation. It is not based on a confirmed manufacturing defect, analytical malfunction, or clinical performance problem. However, as the required conformity documentation could not be confirmed, we are issuing this notice as a precautionary measure.

What you should do:

• Do not use any remaining affected units.
• If you have unused test kits, dispose of them safely with your

household waste/contact us before disposal so that we can inform you about available return, refund, or disposal options.

If you have already used the product, this notification does not necessarily mean that your result was incorrect. However, you should not make or change any medical decisions based solely on the result. If the result influenced a decision regarding your medical care or if you have health concerns, please consult a qualified healthcare professional for further testing and advice.

We apologize for any inconvenience. We are sending this notification to ensure that you have clear information and appropriate guidance while the regulatory matter is being resolved.

For questions or assistance, please contact:

Email: support@testdirect.eu