Safety information regarding in vitro diagnostic medical devices for the detection of sexually transmitted diseases that were obtained via the webshops „thuistest.shop“ and „stdheimtest.de“ New
The Federal Office for Safety in Health Care (BASG) warns against the use of rapid tests for the detection of sexually transmitted diseases (STDs) that were distributed via the website „thuistest.shop“ and “stdheimtest.de“. Based on the information available to the BASG, the legal compliance of the affected products cannot be sufficiently demonstrated and therefore the safety and performance of the products cannot be ensured. For this reason, the listed products are not allowed to be placed on the Union Market.
The Federal Office for Safety in Health Care (BASG) warns against the in-vitro diagnostic devices listed below, as their safety and performance cannot be sufficiently demonstrated.
For this reason, the operator of the afore mentioned website „thuistest.shop“ has initiated a recall of the affected products.
Users of these products are advised not to use any unused tests purchased via the websites thuistest.shop“ and „stdheimtest.de“ and to follow the instructions available at the following link: https://thuistest.shop/de/FAQ_Safety_Notice
| Medical devices | Snel-/rapid-/schnelltest Chlamydia & Gonrroe, EAN: 6150803970964 Snel-/rapid-/schnelltest Combo HIV en Syfilis, EAN: 6150825775738 4-in-1 Snel-/rapid-/schnelltest Chlamydia, Gonrroe, HIV en Syfilis, EAN: 6150857773702 Sneltest HIV, EAN: 6150830655674 HSV 1 + 2 combo rapid test, EAN: 6150842163143 Blood type test, EAN: 7340221708136 10-in-1 SOA Test, EAN: 6150845744738 8-in-1 rapid STD test, EAN: 6153742096061 |
|---|---|
| Manufacturer | Zhuhai Encode Medical Engineering Co., Ltd Baleamed EOOD Get Tested International AB |
| Batch number(s) | The recall affects all tests that were purchased during the following periods via the following websites: Thuistest.shop: June 23, 2024 – January 31, 2026 STDheimtest.de: October 8, 2025 – January 31, 2026 |
| Further information Link | FAQ |
