Austria's BASG Warns Against Non-Compliant Sexually Transmitted Infection Self-Tests Sold Online

Key Summary

Austria's Federal Office for Safety in Health Care (BASG) has published a safety notice stating that several sexually transmitted infection (STI) self-tests sold through the websites thuistest.shop and stdheimtest.de are intended for use by healthcare professionals only, but were incorrectly promoted to lay users. The products concerned include herpes, HPV, syphilis and MPOX tests, with manufacturers including Zhuhai Encode, Mednostic and Hangzhou AllTest. BASG has required the website operator to recall all affected products and advises consumers to stop using them. The case highlights the need for Chinese IVD exporters to ensure that product labelling and intended purpose are consistent with the regulations of the target market.

Source and Applicability

• Source authority: Austrian Federal Office for Safety in Health Care (BASG)
• Date of original notice: 26 May 2026
• Source: BASG official announcements – market surveillance, Sicherheitsinformation betreffend In-vitro-Diagnostika zur Erkennung von sexuell übertragbaren Krankheiten, welche über die Webshops thuistest.shop und stdheimtest.de bezogen wurden (https://www.basg.gv.at/en/market-surveillance/official-announcements/detail/sicherheitsinformation-betreffend-in-vitro-diagnostika-zur-erkennung-von-sexuell-uebertragbaren-krankheiten-welche-ueber-die-webshops-thuistestshop-und-stdheimtestde-bezogen-wurden)
• Applicability: This article is a compilation of publicly available BASG information. The latest official publication of the regulatory authority prevails in all respects.

Full Translation of the Original Notice

Safety Notice | Medical Devices | 26 May 2026

The Federal Office for Safety in Health Care (BASG) warns lay users against using the in vitro diagnostic medical devices listed below, because these devices are intended for use by healthcare professionals only, while the website operator claims that they can be used by lay users for self-testing, which is non-compliant.

The operator of the website thuistest.shop has therefore initiated a recall of the affected products.

Lay users are advised not to use any unused test products purchased via the websites thuistest.shop and stdheimtest.de, and to follow the instructions provided at the following link: https://thuistest.shop/de/FAQ_Safety_Notice

If necessary, please consult a physician.

Affected Medical Devices

• HSV – Herpes simplex virus – Herpes type 2, EAN: 8720892531841
• HSV – Herpes simplex virus – Herpes type 1, EAN: 8720892531834
• HSV 1+2 Combination Rapid Test, EAN: 7340221710047
• Candida albicans Thuistest – Vaginal Rapid Test, EAN: 7340221700888
• HPV Rapid Test, EAN: 7340221708259
• Syphilis Test, EAN: 7340221701656
• MPOX Test, EAN: 7340221708976
• Mycoplasma Test, EAN: 7340221710030

Manufacturers Named in the Notice

• Zhuhai Encode Medical Engineering Co., Ltd.
• Mednostic
• Hangzhou AllTest Biotech Co., Ltd. (ALLTEST)

Batch Numbers

The recall covers all test products purchased through the following websites during the periods indicated:

• thuistest.shop: 23 June 2024 to 31 January 2026
• stdheimtest.de: 8 October 2025 to 31 January 2026

Further Information

• Link to the FAQ: see the operator's safety notice page
• Further enquiries: medizinprodukte@basg.gv.at

AIMEILI Regulatory Interpretation

The BASG notice is a post-market safety and recall communication rather than a policy or guidance update. It requires a differentiated assessment because its implications differ across registration pathways, technical documentation, labelling and instructions for use, risk management and post-market maintenance. It should not be treated merely as industry news.

For Chinese medical device and IVD companies, the priority is to convert the notice into executable compliance actions: confirm whether comparable products, comparable technology routes or comparable risk points are involved; verify whether existing documentation still supports the requirements of the target market; and, where necessary, update risk management files, performance verification data, clinical evaluation, labelling and instructions for use, distributor communications and post-market surveillance records.

From a regulatory standpoint, the central issue is the intended purpose. A device intended for professional use is subject to different requirements from a device intended for self-testing. Under Regulation (EU) 2017/746 (IVDR), self-testing devices are subject to specific requirements, including demonstration of performance by lay users, appropriate labelling and instructions for use, and conformity assessment procedures suitable for self-test devices. Promoting a professional-use device to lay users for self-testing therefore constitutes a change of intended purpose that is not covered by the existing conformity assessment.

Documents to Review on Priority

• Intended purpose and indications for use, including the intended operator (professional use, self-testing or near-patient testing)
• Classification basis and the conformity assessment route applied
• ISO 13485 quality management system certification and scope
• Risk management documentation, including use-related risk for lay users
• Performance evaluation and analytical and clinical performance data
• Labelling, instructions for use and marketing materials, including language versions
• Authorised representative appointment, declarations and existing registration certificates

Common Compliance Risks

• Ambiguous or incorrect determination of classification and intended purpose
• Incomplete evidence chains in technical documentation
• Labelling and instructions for use that are not localised to the target market's language requirements
• Unclear allocation of responsibilities for the authorised representative or importer
• Insufficient arrangements for post-market surveillance, vigilance and field safety corrective action
• Marketing claims on e-commerce platforms that exceed the cleared intended purpose

Business Impact for Manufacturers, Distributors and Exporters

1. Intended purpose must match the target market's regulatory position

The devices in question were designed for professional use, but the websites sold them as self-tests. For IVD products exported to the European Union, companies must determine clearly whether a product falls within the self-testing category and ensure that labels, instructions for use and promotional materials state the intended user unambiguously. Vague or ambiguous wording creates direct regulatory exposure and can lead to recall or withdrawal from the market.

2. Technical documentation and clinical evaluation must reflect self-testing requirements

Where a product is intended for self-testing, the technical documentation must include usability studies with lay users, label comprehension testing and clinical performance data demonstrating safety and effectiveness in the intended population. The BASG notice illustrates that the intended user population must be settled at the registration stage and supported by corresponding clinical evidence.

3. Labelling and instructions for use must meet EU language and warning requirements

In this case, key information such as "for professional use only" or "not for self-testing" may not have been clearly stated, resulting in misleading claims. Manufacturers should ensure that labels cover restrictions on use, warning statements and the correct intended purpose, and that multilingual versions meet EU language requirements, in order to avoid market complaints or regulatory action.

4. Post-market surveillance and complaint handling must enable rapid response

BASG required the website operator to initiate a recall, underlining the importance of effective post-market surveillance (PMS) and vigilance systems. Chinese IVD companies should appoint an EU authorised representative (EC REP) or local agent able to receive regulatory warnings promptly and to organise recalls or field safety corrective actions (FSCA). Product records and batch traceability systems must also be robust enough to identify affected batches quickly.

5. E-commerce and distributor channels require compliance oversight

As cross-border e-commerce expands, many manufacturers sell through third-party websites. BASG's action shows that authorities will follow online sales activity back to the products and the responsible economic operators. Companies should audit distributors and online sales platforms, maintain a compliance checklist for overseas sales channels, and review product descriptions and claims on e-commerce platforms periodically to reduce regulatory risk.

6. Commercial consequences

Beyond the recall itself, the notice carries commercial implications for affected manufacturers and their distribution partners: reputational exposure in the EU market, potential scrutiny of other products in the same portfolio, disruption of distributor relationships, and the need to re-verify conformity before products can return to the market. Exporters should assess whether similar products are offered for self-testing in other EU member states and take corrective action proactively rather than waiting for further regulatory notices.

Frequently Asked Questions

Can this BASG safety notice be used directly as a basis for a regulatory submission?

No. This article is intended for preliminary understanding and project assessment only. A formal submission must be based on the latest requirements of the target country's regulatory authority, the concluded classification of the product and the company's actual documentation.

What should a company do first after seeing a regulatory update of this kind?

A documentation gap assessment should be carried out first, to confirm whether the update affects the registration pathway, technical documentation, labelling, quality management system or post-market maintenance obligations. Where comparable products are identified, the assessment should be documented and, if necessary, followed by corrective actions and communication with the authorised representative and distributors.

Content Review and Scope of Application

• Author: AIMEILI Regulatory Editorial Team
• Professional review: AIMEILI International Medical Device Registration Project Team
• Source principle: Official regulatory authorities, international organisations, standards bodies and publicly available regulatory texts are prioritised; industry media and project experience are used only as supporting references.
• Scope: This article supports preliminary understanding, document preparation and project planning. It does not replace the formal requirements of the target country's regulatory authority, testing conclusions or legal advice.

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