Safety alert for DermaGenius 3.0 reagent

The ANSM has issued a safety alert (Information n° R2607183) concerning the DermaGenius 3.0 Complete Multiplex real-time PCR reagent, following a security action initiated by the manufacturer, PathoNostics. The alert is directed at medical biology analysis laboratories, and users have been notified via a letter from the company. The ANSM is not the direct issuer of the security action but is registering it and providing information to affected parties.

Laboratories using this reagent should review the security action details provided by PathoNostics, as outlined in the letter dated March 13, 2026. For specific questions or to understand the implications of this security action, laboratories should contact PathoNostics directly. The ANSM's role here is informational, ensuring awareness within the regulated community.