Frequently Asked Questions about Field Safety Notice (FSN)
Read the Field Safety Notice here
We understand that the Field Safety Notice email may raise questions.
We will do our best to answer as many of your questions as possible on this page.
Don't forget to register whether you have already used the tests and/or if you have any unused tests. You can do this via the special form (English only). You will find a link below. Thank you in advance for your cooperation.
Frequently Asked Questions – Safety Notice STI Self-Tests
Why am I receiving this safety notice?
You are receiving this safety notice because certain self-tests sold through our webshops were placed on the EU market without a valid CE marking according to the applicable IVD legislation. For this reason, we have initiated a voluntary product recall.
Does this mean the tests are unsafe?
No. At this time, no product defects, technical faults, or reports of health damage are known. The recall has been initiated due to a regulatory non-compliance related to CE marking, not because of a confirmed product defect.
Why are the tests being recalled then?
According to European regulations, medical self-tests may only be sold if they meet all certification requirements for CE marking. During an inspection it was determined that certain tests did not have this certification and, according to the regulations, should only have been sold with the label “For professional use”, intended for use by healthcare professionals. In addition, some of the products did not include a Dutch-language instruction manual, which creates a risk that the test could be used incorrectly.
What does the label “For professional use” mean?
“For professional use” means that the test is intended only for use by a healthcare professional, such as a doctor, nurse, or laboratory professional. This means the test must be performed and/or interpreted by a professional and that medical knowledge or training may be required for proper use. The test is not approved as a self-test for home use by consumers. In other words, according to the regulations the product may not be sold directly to consumers for personal use at home, but only through a healthcare professional.
Which products are affected by this recall?
The recall concerns certain self-tests from the brands ENCODE, GET TESTED, MEDNOSTIC, and BALEAMED. The products were packaged in packaging from ThuisTest.shop or STDheimtest.de. This includes tests for: Chlamydia, Gonorrhea, HIV, Syphilis, Herpes (HSV), HPV, Candida, MPOX, Urinary Tract Infection, Blood Group, and 8-in-1 / 10-in-1 STI tests.
During which period were these tests sold?
The affected tests were sold during the following period:
Thuistest.shop: 23 June 2024 – 31 January 2026
STDheimtest.de: 8 October 2025 – 31 January 2026
How do I know if my test is affected by the recall?
If you purchased one of the tests mentioned above during the stated period through Thuistest.shop or STDheimtest.de, your test may fall under this safety notice.
What should I do if I still have an unused test?
Please do not use the test anymore. We ask you to confirm via the dedicated registration page that you have received this safety notice and indicate whether you are still in possession of the product:
If you have already used all kit(s):
https://twrxnhzs.formester.com/f/2dbVjHTOy
If you still have unused kit(s):
https://twrxnhzs.formester.com/f/zhuWyph7b
After registration you will receive further instructions on what to do with the product, for example whether the unused product can be disposed of or needs to be returned.
Do I need to return the test?
We first ask you to confirm via the registration page that you have received this safety notice and indicate whether you still have the product. After registration you will receive further instructions.
If you have already used all kit(s):
https://twrxnhzs.formester.com/f/2dbVjHTOy
If you still have unused kit(s):
https://twrxnhzs.formester.com/f/zhuWyph7b
I already used the test. What should I do?
In most cases you do not need to take any action. However, we recommend contacting a doctor or testing location if you have symptoms, if you may have been exposed to an STI risk, or if you have doubts about your test result.
Could my test result be incorrect?
There have been no reports of incorrect results. However, because the tests were not formally assessed as CE-certified self-tests, we cannot fully guarantee their performance for home use under EU regulations.
I had a negative test result. Should I get tested again?
This may be advisable if you have symptoms, if you were recently exposed to a potential infection risk, or if you would like additional certainty. In that case you can get tested through a doctor, public health service, clinic, or order a laboratory test through our website.
I had a positive test result. What should I do?
Please contact a doctor, public health service, or medical testing location for a confirmatory test and possible treatment.
Have any health problems been reported from these tests?
No. So far, no incidents or health damage have been reported in connection with these products.
Why were these tests sold in the first place?
During the transition from the former European regulation IVDD to the new IVDR regulation, a misunderstanding occurred regarding the CE certification status of the OEM product. Once this was discovered, we immediately stopped sales and initiated this voluntary recall.
More information about EU medical device regulations:
https://health.ec.europa.eu/medical-devices-sector/new-regulations_en
Have the authorities been informed?
Yes. The recall has been reported to the Inspectie Gezondheidszorg en Jeugd (IGJ) in the Netherlands and to the Swedish Medical Products Agency (Läkemedelsverket) via the supplier.
https://www.lakemedelsverket.se
Is it still safe to use STI self-tests?
Yes. Many correctly CE-certified self-tests are available on the market and can be used safely. Always check for a valid CE marking for self-tests. At the moment we do not offer these self-tests. We are in discussions with suppliers to have the products certified for home/self-testing use. This certification process may take some time. Until then, only laboratory tests can be ordered via our website.
Does this recall apply to all products on your website?
No. This safety notice applies only to the specifically mentioned tests. All laboratory tests are excluded from this recall. Other products on our website are also not affected.
Are these tests still being sold?
No. The sale and distribution of the affected tests have been stopped immediately. We currently sell only laboratory tests.
Can I receive a refund for my purchase?
If you purchased an affected product but have not used it, you can register the product through the response form. After registration you will receive instructions on how to return the product to us free of charge. Once we have received the unused product, we will refund the full purchase amount.
What are you doing to prevent this in the future?
We have initiated internal Corrective and Preventive Actions (CAPA) to further strengthen our procedures regarding product selection, CE certification, and regulatory review.
https://en.wikipedia.org/wiki/Corrective_and_preventive_action
Should I be concerned about my health?
For most users the risk is low. If you have symptoms or doubts about a previous test result, we recommend a professional test through a healthcare provider.
How reliable are tests performed by a doctor, clinic, or laboratory?
Tests performed by a doctor, clinic, or laboratory use certified medical diagnostics and generally provide the highest level of reliability.
How can I check whether a medical test is CE certified?
A medical test should have a CE marking and, where required, a notified body number. It should also clearly state that the test is suitable for self-testing, and not, as was indicated on some of our packaging and instructions, labeled “For professional use only.”
Why do you recommend a professional test if there is doubt?
The affected products are intended as screening tests and provide only a preliminary indication. Because the tests have not been formally assessed as CE-certified self-tests under the current EU legislation, we recommend that if you have symptoms, possible infection exposure, or doubts about a test result, you obtain a professional test through a doctor, public health service, clinic, or via a laboratory test on our website. Professional diagnostics provide the most reliable confirmation, and such tests are often required to start treatment in the event of a positive result.
Who can I contact if I have questions?
You can contact:
Strolenberg B.V. – Thuistest.shop / STDheimtest.de
support@thuistest.shop
kundenservice@stdheimtest.de
Our team is happy to help you.